E-tender for Rate Contract for Supply of Lifesaving Permanent Implant Product (Item), for Lifesaving Cardiac Operations and Cardiac Procedures (Adult, Paediatric & Neonatal) i.e. Heart Valve and Heart Valve Ring for U N Mehta Institute of Cardiology and Research Centre (Affiliated to B. J. Medical College & NABH Accredited) Ahmedabad, Gujarat, India.

Technical Compliance Sheet of E - Tender for Rate Contract for Supply of Heart Valve and Heart Valve Ring, E - Tender ID # 302103

SN Product (Item) Name Product (Item) Description Required Size Mandatory Product (item) Certification Required for Product (item) Qualification Unit Brand Name Manufacturing Company Reference No. Quoted Size Compliance to the Tender Specification (Yes/No) Deviation, If any

1 Mechanical Bi Leaflet Heart Valve Rotatable (Aortic) - All Sizes USFDA approved 1

2 Mechanical Bi Leaflet Heart Valve Rotatable (Aortic) - All Sizes CE approved 1

3 Mechanical Bi Leaflet Heart Valve Rotatable (Aortic) - All Sizes DCGI approved 1

4 Mechanical Bi Leaflet Heart Valve Rotatable (Mitral) - All Sizes USFDA approved 1

5 Mechanical Bi Leaflet Heart Valve Rotatable (Mitral) - All Sizes CE approved 1

6 Mechanical Bi Leaflet Heart Valve Rotatable (Mitral) - All Sizes DCGI approved 1

7 Mechanical Bi Leaflet Heart Valve Rotatable for small aortic root with best effective orifice area (EOA) and geometric orifice area Quoted series should have minimum available size of 17mm Effective orifice Area (EOA) for the 17 mm size shuold be more than 1.4 cm2 All Sizes USFDA approved 1

8 Mechanical Bi Leaflet Heart Valve Rotatable for small aortic root with best effective orifice area (EOA) and geometric orifice area Quoted series should have minimum available size of 17mm Effective orifice Area (EOA) for the 17 mm size shuold be more than 1.4 cm2 All Sizes CE approved 1

9 Mechanical Bi Leaflet Heart Valve Rotatable for small aortic root with best effective orifice area (EOA) and geometric orifice area Quoted series should have minimum available size of 17mm Effective orifice Area (EOA) for the 17 mm size shuold be more than 1.4 cm2 All Sizes DCGI approved 1

10 Bovine Tissue Valve (Aortic) Quoted series should have minimum available size of 19mm All Sizes USFDA approved 1

11 Bovine Tissue Valve (Aortic) Quoted series should have minimum available size of 19mm All Sizes CE approved 1

12 Bovine Tissue Valve (Aortic) Quoted series should have minimum available size of 19mm All Sizes DCGI approved 1

13 Bovine Tissue Valve (Mitral) - All Sizes USFDA approved 1

14 Bovine Tissue Valve (Mitral) - All Sizes CE approved 1

15 Bovine Tissue Valve (Mitral) - All Sizes DCGI approved 1

16 Porcine Tissue Valve (Aortic) - All Sizes USFDA approved 1

17 Porcine Tissue Valve (Aortic) - All Sizes CE approved 1

18 Porcine Tissue Valve (Aortic) - All Sizes DCGI approved 1

19 Porcine Tissue Valve (Mitral) - All Sizes USFDA approved 1

20 Porcine Tissue Valve (Mitral) - All Sizes CE approved 1

21 Porcine Tissue Valve (Mitral) - All Sizes DCGI approved 1

22 Porcine Tissue Valve for Small Aortic Root Quoted series should have minimum available size of 19mm All Sizes USFDA approved 1

23 Porcine Tissue Valve for Small Aortic Root Quoted series should have minimum available size of 19mm All Sizes CE approved 1

24 Porcine Tissue Valve for Small Aortic Root Quoted series should have minimum available size of 19mm All Sizes DCGI approved 1

25 Pulmonary Conduit Tissue Heart Valve - All Sizes USFDA approved 1

26 Pulmonary Conduit Tissue Heart Valve - All Sizes CE approved 1

27 Pulmonary Conduit Tissue Heart Valve - All Sizes DCGI approved 1

28 Conduit with Mechanical Valve (Aortic) Albumin Coated or Collagen Coated All Sizes USFDA approved 1

29 Conduit with Mechanical Valve (Aortic) Albumin Coated or Collagen Coated All Sizes CE approved 1

30 Conduit with Mechanical Valve (Aortic) Albumin Coated or Collagen Coated All Sizes DCGI approved 1

31 Stentless Aortic Tissue Valve - All Sizes USFDA approved 1

32 Stentless Aortic Tissue Valve - All Sizes CE approved 1

33 Stentless Aortic Tissue Valve - All Sizes DCGI approved 1

34 Sutureless Aortic Valve - All Sizes USFDA approved 1

35 Sutureless Aortic Valve - All Sizes CE approved 1

36 Sutureless Aortic Valve - All Sizes DCGI approved 1

37 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Supra annular, Porcine Pericardium Transcatheter Aortic Heart Valve without Skirt All Sizes USFDA approved 1

38 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Supra annular, Porcine Pericardium Transcatheter Aortic Heart Valve without Skirt All Sizes CE approved 1

39 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Supra annular, Porcine Pericardium Transcatheter Aortic Heart Valve without Skirt All Sizes DCGI approved 1

40 Transcatheter Aortic Heart Valve (Self Expandable) Self Expanding, Supra annular, Recapturable Porcine Pericardium Transcatheter Aortic Heart Valve with 3 markers on the commissures and Delivery system with Single Spine Shaft All Sizes USFDA approved 1

41 Transcatheter Aortic Heart Valve (Self Expandable) Self Expanding, Supra annular, Recapturable Porcine Pericardium Transcatheter Aortic Heart Valve with 3 markers on the commissures and Delivery system with Single Spine Shaft All Sizes CE approved 1

42 Transcatheter Aortic Heart Valve (Self Expandable) Self Expanding, Supra annular, Recapturable Porcine Pericardium Transcatheter Aortic Heart Valve with 3 markers on the commissures and Delivery system with Single Spine Shaft All Sizes DCGI approved 1

43 Transcatheter Aortic Heart Valve (Self Expandable) Self Expanding, Supra annular, Recapturable Porcine Pericardium Transcatheter Aortic Heart Valve with Skirt, Delivery system with Single Spine Shaft, Larger window in front of coronaty to facilitate coronary access. All Sizes USFDA approved 1

44 Transcatheter Aortic Heart Valve (Self Expandable) Self Expanding, Supra annular, Recapturable Porcine Pericardium Transcatheter Aortic Heart Valve with Skirt, Delivery system with Single Spine Shaft, Larger window in front of coronaty to facilitate coronary access. All Sizes CE approved 1

45 Transcatheter Aortic Heart Valve (Self Expandable) Self Expanding, Supra annular, Recapturable Porcine Pericardium Transcatheter Aortic Heart Valve with Skirt, Delivery system with Single Spine Shaft, Larger window in front of coronaty to facilitate coronary access. All Sizes DCGI approved 1

46 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Supra annular, Porcine Pericardium Transcatheter Aortic Heart Valve with Skirt All Sizes USFDA approved 1

47 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Supra annular, Porcine Pericardium Transcatheter Aortic Heart Valve with Skirt All Sizes CE approved 1

48 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Supra annular, Porcine Pericardium Transcatheter Aortic Heart Valve with Skirt All Sizes DCGI approved 1

49 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Intra annular, Recapturable Bovine Pericardium Transcatheter Aortic Heart Valve All Sizes USFDA approved 1

50 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Intra annular, Recapturable Bovine Pericardium Transcatheter Aortic Heart Valve All Sizes CE approved 1

51 Transcatheter Aortic Heart Valve (Self Expandable) Self-Expanding, Intra annular, Recapturable Bovine Pericardium Transcatheter Aortic Heart Valve All Sizes DCGI approved 1

52 Transcatheter Aortic Heart Valve (Balloon Expandable) Balloon-Expanding, Intra annular, Bovine Pericardium Transcatheter Aortic Heart Valve All Sizes USFDA approved 1

53 Transcatheter Aortic Heart Valve (Balloon Expandable) Balloon-Expanding, Intra annular, Bovine Pericardium Transcatheter Aortic Heart Valve All Sizes CE approved 1

54 Transcatheter Aortic Heart Valve (Balloon Expandable) Balloon-Expanding, Intra annular, Bovine Pericardium Transcatheter Aortic Heart Valve All Sizes DCGI approved 1

55 Transcatheter Mitral Heart Valve - All Sizes USFDA approved 1

56 Transcatheter Mitral Heart Valve - All Sizes CE approved 1

57 Transcatheter Mitral Heart Valve - All Sizes DCGI approved 1

58 Transcatheter Pulmonary Heart Valve With a bovine jugular vein valve mounted on platinum iridium stent and having a balloon in the balloon delivery system All Sizes USFDA approved 1

59 Transcatheter Pulmonary Heart Valve With a bovine jugular vein valve mounted on platinum iridium stent and having a balloon in the balloon delivery system All Sizes CE approved 1

60 Transcatheter Pulmonary Heart Valve With a bovine jugular vein valve mounted on platinum iridium stent and having a balloon in the balloon delivery system All Sizes DCGI approved 1

61 Transcatheter Pulmonary Heart Valve Self Expanding, Fully Sheathable Porcine pericardial tissue valve All Sizes USFDA approved 1

62 Transcatheter Pulmonary Heart Valve Self Expanding, Fully Sheathable Porcine pericardial tissue valve All Sizes CE approved 1

63 Transcatheter Pulmonary Heart Valve Self Expanding, Fully Sheathable Porcine pericardial tissue valve All Sizes DCGI approved 1

64 Transcatheter Tricuspid Heart Valve - All Sizes USFDA approved 1

65 Transcatheter Tricuspid Heart Valve - All Sizes CE approved 1

66 Transcatheter Tricuspid Heart Valve - All Sizes DCGI approved 1

67 Transcatheter Miral Valve Repair Clip Transcatheter Edge to Edge repair for Mitral Valve All Sizes USFDA approved 1

68 Transcatheter Miral Valve Repair Clip Transcatheter Edge to Edge repair for Mitral Valve All Sizes CE approved 1

69 Transcatheter Miral Valve Repair Clip Transcatheter Edge to Edge repair for Mitral Valve All Sizes DCGI approved 1

70 Bovine Pericardial Stented Aortic Tissue Valve, Dry Tissue Heart Valve - All Sizes USFDA approved 1

71 Bovine Pericardial Stented Aortic Tissue Valve, Dry Tissue Heart Valve - All Sizes CE approved 1

72 Bovine Pericardial Stented Aortic Tissue Valve, Dry Tissue Heart Valve - All Sizes DCGI approved 1

73 Bovine Pericardial Stented Mitral Tissue Valve, Dry Tissue Heart Valve - All Sizes USFDA approved 1

74 Bovine Pericardial Stented Mitral Tissue Valve, Dry Tissue Heart Valve - All Sizes CE approved 1

75 Bovine Pericardial Stented Mitral Tissue Valve, Dry Tissue Heart Valve - All Sizes DCGI approved 1

76 Synthetic Bicuspid Valved Conduit for Right Ventricular Outflow Tract Reconstruction - All Sizes USFDA approved 1

77 Synthetic Bicuspid Valved Conduit for Right Ventricular Outflow Tract Reconstruction - All Sizes CE approved 1

78 Synthetic Bicuspid Valved Conduit for Right Ventricular Outflow Tract Reconstruction - All Sizes DCGI approved 1

79 Mono-Leaflet Tilting Disc Heart Valve (Aortic) - All Sizes USFDA approved 1

80 Mono-Leaflet Tilting Disc Heart Valve (Aortic) - All Sizes CE approved 1

81 Mono-Leaflet Tilting Disc Heart Valve (Aortic) - All Sizes DCGI approved 1

82 Mono-Leaflet Tilting Disc Heart Valve (Mitral) - All Sizes USFDA approved 1

83 Mono-Leaflet Tilting Disc Heart Valve (Mitral) - All Sizes CE approved 1

84 Mono-Leaflet Tilting Disc Heart Valve (Mitral) - All Sizes DCGI approved 1

85 Implantable Ventricular Assist Device (VAD) Temporary, For Open Heart Surgical Implantation Adult USFDA approved 1

86 Implantable Ventricular Assist Device (VAD) Temporary, For Open Heart Surgical Implantation Adult CE approved 1

87 Implantable Ventricular Assist Device (VAD) Temporary, For Open Heart Surgical Implantation Adult DCGI approved 1

88 Implantable Ventricular Assist Device (VAD) Temporary, For Open Heart Surgical Implantation Paediatric USFDA approved 1

89 Implantable Ventricular Assist Device (VAD) Temporary, For Open Heart Surgical Implantation Paediatric CE approved 1

90 Implantable Ventricular Assist Device (VAD) Temporary, For Open Heart Surgical Implantation Paediatric DCGI approved 1

91 Implantable Ventricular Assist Device (VAD) Destination Therapy, For Open Heart Surgical Implantation Adult USFDA approved 1

92 Implantable Ventricular Assist Device (VAD) Destination Therapy, For Open Heart Surgical Implantation Adult CE approved 1

93 Implantable Ventricular Assist Device (VAD) Destination Therapy, For Open Heart Surgical Implantation Adult DCGI approved 1

94 Implantable Ventricular Assist Device (VAD) Destination Therapy, For Open Heart Surgical Implantation Paediatric USFDA approved 1

95 Implantable Ventricular Assist Device (VAD) Destination Therapy, For Open Heart Surgical Implantation Paediatric CE approved 1

96 Implantable Ventricular Assist Device (VAD) Destination Therapy, For Open Heart Surgical Implantation Paediatric DCGI approved 1

97 Rigid Ischaemic Mitral Annuloplasty Heart Valve Ring Should have a complete rigid ring, To be constructed of a strong, durable alloy, Should have a increased sewing margin in the P2-P3 region, Should be marked with suture and designed to accommodate a double suture row, Should have a Dipped P3 region to accommodate higher stresses from downward LV displacement, Should have a convenient holder/handle to increase ease of use & operative efficiency All Sizes USFDA approved 1

98 Rigid Ischaemic Mitral Annuloplasty Heart Valve Ring Should have a complete rigid ring, To be constructed of a strong, durable alloy, Should have a increased sewing margin in the P2-P3 region, Should be marked with suture and designed to accommodate a double suture row, Should have a Dipped P3 region to accommodate higher stresses from downward LV displacement, Should have a convenient holder/handle to increase ease of use & operative efficiency All Sizes CE approved 1

99 Rigid Ischaemic Mitral Annuloplasty Heart Valve Ring Should have a complete rigid ring, To be constructed of a strong, durable alloy, Should have a increased sewing margin in the P2-P3 region, Should be marked with suture and designed to accommodate a double suture row, Should have a Dipped P3 region to accommodate higher stresses from downward LV displacement, Should have a convenient holder/handle to increase ease of use & operative efficiency All Sizes DCGI approved 1

100 Rigid - 2D Non-Ischaemic Mitral Annuloplasty Heart Valve Ring Two dimentional (2D) design, AP to transverse diameter should be atleast 3:4 All Sizes USFDA approved 1

101 Rigid - 2D Non-Ischaemic Mitral Annuloplasty Heart Valve Ring Two dimentional (2D) design, AP to transverse diameter should be atleast 3:4 All Sizes CE approved 1

102 Rigid - 2D Non-Ischaemic Mitral Annuloplasty Heart Valve Ring Two dimentional (2D) design, AP to transverse diameter should be atleast 3:4 All Sizes DCGI approved 1

103 Rigid - 3D Non-Ischaemic Mitral Annuloplasty Heart Valve Ring Three dimentional (3D) design, Saddle Shape All Sizes USFDA approved 1

104 Rigid - 3D Non-Ischaemic Mitral Annuloplasty Heart Valve Ring Three dimentional (3D) design, Saddle Shape All Sizes CE approved 1

105 Rigid - 3D Non-Ischaemic Mitral Annuloplasty Heart Valve Ring Three dimentional (3D) design, Saddle Shape All Sizes DCGI approved 1

106 Semi Rigid - Anterior Flexible Non-Ischaemic Mitral Annuloplasty Heart Valve Ring - All Sizes USFDA approved 1

107 Semi Rigid - Anterior Flexible Non-Ischaemic Mitral Annuloplasty Heart Valve Ring - All Sizes CE approved 1

108 Semi Rigid - Anterior Flexible Non-Ischaemic Mitral Annuloplasty Heart Valve Ring - All Sizes DCGI approved 1

109 Semi Rigid - Posterior Flexible Non-Ischaemic Mitral Annuloplasty Heart Valve Ring - All Sizes USFDA approved 1

110 Semi Rigid - Posterior Flexible Non-Ischaemic Mitral Annuloplasty Heart Valve Ring - All Sizes CE approved 1

111 Semi Rigid - Posterior Flexible Non-Ischaemic Mitral Annuloplasty Heart Valve Ring - All Sizes DCGI approved 1

112 Rigid Tricuspid Annuloplasty Heart Valve Ring - All Sizes USFDA approved 1

113 Rigid Tricuspid Annuloplasty Heart Valve Ring - All Sizes CE approved 1

114 Rigid Tricuspid Annuloplasty Heart Valve Ring - All Sizes DCGI approved 1

115 Flexible Tricuspid Annuloplasty Heart Valve Ring - All Sizes USFDA approved 1

116 Flexible Tricuspid Annuloplasty Heart Valve Ring - All Sizes CE approved 1

117 Flexible Tricuspid Annuloplasty Heart Valve Ring - All Sizes DCGI approved 1

118 Rigid 3D Shape Tricuspid Annuloplasty Heart Valve Ring - All Sizes USFDA approved 1

119 Rigid 3D Shape Tricuspid Annuloplasty Heart Valve Ring - All Sizes CE approved 1

120 Rigid 3D Shape Tricuspid Annuloplasty Heart Valve Ring - All Sizes DCGI approved 1

121 Semi Rigid Mitral Annuloplasty Heart Valve Ring with Loops for Neochordae - All Sizes USFDA approved 1

122 Semi Rigid Mitral Annuloplasty Heart Valve Ring with Loops for Neochordae - All Sizes CE approved 1

123 Semi Rigid Mitral Annuloplasty Heart Valve Ring with Loops for Neochordae - All Sizes DCGI approved 1

124 IABP Balloon Catheter - 7Fr, 30CC USFDA approved 1

125 IABP Balloon Catheter - 7Fr, 30CC CE approved 1

126 IABP Balloon Catheter - 7Fr, 30CC DCGI approved 1

127 IABP Balloon Catheter - 7.5Fr, 34CC USFDA approved 1

128 IABP Balloon Catheter - 7.5Fr, 34CC CE approved 1

129 IABP Balloon Catheter - 7.5Fr, 34CC DCGI approved 1

130 IABP Balloon Catheter - 7.5Fr, 40CC USFDA approved 1

131 IABP Balloon Catheter - 7.5Fr, 40CC CE approved 1

132 IABP Balloon Catheter - 7.5Fr, 40CC DCGI approved 1

133 IABP Balloon Catheter - 8Fr, 40CC USFDA approved 1

134 IABP Balloon Catheter - 8Fr, 40CC CE approved 1

135 IABP Balloon Catheter - 8Fr, 40CC DCGI approved 1

136 IABP Balloon Catheter - 8Fr, 50CC USFDA approved 1

137 IABP Balloon Catheter - 8Fr, 50CC CE approved 1

138 IABP Balloon Catheter - 8Fr, 50CC DCGI approved 1

139 Wire-Reinforced IABP Balloon Catheter - All Sizes USFDA approved 1

140 Wire-Reinforced IABP Balloon Catheter - All Sizes CE approved 1

141 Wire-Reinforced IABP Balloon Catheter - All Sizes DCGI approved 1

142 Fiber Optic IABP Catheter - All Sizes USFDA approved 1

143 Fiber Optic IABP Catheter - All Sizes CE approved 1

144 Fiber Optic IABP Catheter - All Sizes DCGI approved 1

Note: - “Same models and Brands shall not be quoted in two different categories with different Product (Item) Description (Technical Specifications) of Heart Valve Ring”.