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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131245
In Commercial Distribution

  • 00801741052613 ()

  • Length: 45 Centimeter
131245

  • Ureteral introduction sheath
AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131235
In Commercial Distribution

  • 00801741052606 ()

  • Length: 35 Centimeter
131235

  • Ureteral introduction sheath
AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131225
In Commercial Distribution

  • 00801741052590 ()

  • Length: 25 Centimeter
131225

  • Ureteral introduction sheath
AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131155
In Commercial Distribution

  • 00801741052583 ()

  • Length: 55 Centimeter
131155

  • Ureteral introduction sheath
AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131145
In Commercial Distribution

  • 00801741052576 ()

  • Length: 45 Centimeter
131145

  • Ureteral introduction sheath
AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131135
In Commercial Distribution

  • 00801741052569 ()

  • Length: 35 Centimeter
131135

  • Ureteral introduction sheath
AquaGuide® Ureteral Access Sheath
C. R. Bard, Inc.
131125
In Commercial Distribution

  • 00801741052552 ()

  • Length: 25 Centimeter
131125

  • Ureteral introduction sheath
No Description
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-B-BV01
In Commercial Distribution

  • 26970401813548 ()
  • 16970401813534 ()
  • 06970401813520 ()


  • Endoscopic biopsy valve, sterile
No Description
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-A-BV01
In Commercial Distribution

  • 06970401812585 ()
  • 16970401813244 ()
  • 26970401813258 ()


  • Endoscopic biopsy valve, sterile
ClearGuard Disposable Biopsy Valve for Pentax GI Endoscopes
Zhejiang Chuangxiang Medical Technology Co., LTD.
MDBV1B0000A
In Commercial Distribution

  • 26970401814071 ()
  • 16970401814067 ()
  • 06970401812400 ()
000523

  • Endoscopic biopsy valve, sterile
ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes
Zhejiang Chuangxiang Medical Technology Co., LTD.
MDBV1A0000A
In Commercial Distribution

  • 26970401814057 ()
  • 16970401814043 ()
  • 06970401812387 ()
000522

  • Endoscopic biopsy valve, sterile
Disposable Biopsy Valve
Smartdata Suzhou Co., Ltd.
GAR018P-S
In Commercial Distribution

  • 26970661242287 ()
  • 16970661242280 ()
  • 06970661242283 ()


  • Endoscopic biopsy valve, sterile
No Description
Smartdata Suzhou Co., Ltd.
GAR018-S
In Commercial Distribution

  • 26970661241532 ()
  • 16970661241535 ()
  • 06970661241538 ()


  • Endoscopic biopsy valve, sterile
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1D00
In Commercial Distribution

  • 06972197482300 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1C00
In Commercial Distribution

  • 06972197482287 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1800
In Commercial Distribution

  • 06972197482225 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1D01
In Commercial Distribution

  • 06972197482317 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1C01
In Commercial Distribution

  • 06972197482294 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1B01
In Commercial Distribution

  • 06972197482270 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1B00
In Commercial Distribution

  • 06972197482263 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1A01
In Commercial Distribution

  • 06972197482256 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1A00
In Commercial Distribution

  • 06972197482249 ()


  • Ureteral introduction sheath
No Description
Hunan Vathin Medical Instrument Co., Ltd
UA-S1801
In Commercial Distribution

  • 06972197482232 ()


  • Ureteral introduction sheath
The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-3893AE
In Commercial Distribution

  • 00849111075107 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 9.3 French
8700-0657-40

  • Intravascular core temperature regulation system catheter
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8110.DIL01
In Commercial Distribution

  • 08717872020952 ()
  • 18717872020959 ()
8110.DIL01

  • Surgical irrigation/aspiration tubing set
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.B
Not in Commercial Distribution

  • 08717872000619 ()
  • 18717872000616 ()
1250.B

  • Surgical irrigation/aspiration tubing set
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.ABD
In Commercial Distribution

  • 08717872000602 ()
  • 18717872000609 ()
1250.ABD

  • Surgical irrigation/aspiration tubing set
ADAPTER AP40AST AFFINITY CP WW
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00643169272248 ()


  • Cardiopulmonary bypass system centrifugal pump
ADAPTER AP40AST AFFINITY CP US
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00643169272231 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BPX-80T BIOPUMP 6HR W/TRILLIUM 3L
MEDTRONIC, INC.
BPX-80T
Not in Commercial Distribution

  • 00643169630628 ()

  • Lumen/Inner Diameter: 9.53 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L
MEDTRONIC, INC.
CBBP50
In Commercial Distribution

  • 00643169630604 ()

  • Lumen/Inner Diameter: 6.35 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
MEDTRONIC, INC.
CBBPX-80
In Commercial Distribution

  • 00643169630581 ()

  • Lumen/Inner Diameter: 9.53 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20643169855216 ()
  • 00643169855212 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20643169855209 ()
  • 00643169855205 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20643169855193 ()
  • 00643169855199 ()


  • Cardiopulmonary bypass system centrifugal pump
The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
Zoll Circulation, Inc.
TG2-500D
In Commercial Distribution

  • 00849111075862 ()

  • Length: 6 Feet
8700-001027-01

  • Intravascular core temperature regulation system start kit
The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
Zoll Circulation, Inc.
TG2-500D, Extended Length
In Commercial Distribution

  • 00849111075879 ()

  • Length: 9 Feet
8700-001028-01

  • Intravascular core temperature regulation system start kit
PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20613994647867 ()
  • 00613994647863 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20613994647850 ()
  • 00613994647856 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20613994647843 ()
  • 00613994647849 ()


  • Cardiopulmonary bypass system centrifugal pump
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