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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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Hemolung® 15.5 Fr Femoral Catheter Kit - 00850046004278

Hemolung® 15.5 Fr Femoral Catheter Kit
Alung Technologies, Inc.
40600
Not in Commercial Distribution

  • 00850046004278 ()


  • Mobile extracorporeal gas exchange system

Hemolung® Cartridge with Blood Tubing - 00850046004254

Hemolung® Cartridge with Blood Tubing
Alung Technologies, Inc.
40400
Not in Commercial Distribution

  • 00850046004254 ()


  • Mobile extracorporeal gas exchange system

Hemolung® Rinse Back Kit - 00850046004247

Hemolung® Rinse Back Kit
Alung Technologies, Inc.
40300
Not in Commercial Distribution

  • 00850046004247 ()


  • Mobile extracorporeal gas exchange system

Hemolung® Accessories Kit - 00850046004230

Hemolung® Accessories Kit
Alung Technologies, Inc.
40200
Not in Commercial Distribution

  • 00850046004230 ()


  • Mobile extracorporeal gas exchange system

Hemolung® Cartridge Kit - 00850046004223

Hemolung® Cartridge Kit
Alung Technologies, Inc.
40100
Not in Commercial Distribution

  • 00850046004223 ()


  • Mobile extracorporeal gas exchange system

Hemolung® CR4 Controller - 00850046004056

Hemolung® CR4 Controller
Alung Technologies, Inc.
21000
Not in Commercial Distribution

  • 00850046004056 ()


  • Mobile extracorporeal gas exchange system

Centurion - 00653160002003

C.A.P.D. TUBING EXCHANGE TRAY
CENTURION MEDICAL PRODUCTS CORPORATION
HT80
In Commercial Distribution

  • 50653160002008 ()
  • 00653160002003 ()
HT80

  • General surgical procedure kit, non-medicated, single-use

Trapper™ Exchange Device - 05391526210154

Trapper™ Exchange Device
CREGANNA UNLIMITED COMPANY
H74939330130
In Commercial Distribution

  • 05391526210154 ()

  • Trapper is designed for use with guide catheters having internal lumen diameters in the range of 6F to 8F
  • Lumen OD: 2.0F (≤0.66mm)
  • Balloon length: 10mm
  • Working length: 97-112cm
H74939330130

  • Coronary angioplasty balloon catheter, basic

Sterling Medical Products - 00685404001770

NEONATAL EXCHANGE TRANSFUSION TRAY
APOLLO MEDICAL PRODUCTS CORP.
ETT-NW
In Commercial Distribution

  • 10685404001777 ()
  • 00685404001770 ()


  • General surgical procedure kit, medicated

ACS - 00191072195661

G-J TUBE EXCHANGE TRAY
AMERICAN CONTRACT SYSTEMS, INC.
MCGJ15A
In Commercial Distribution

  • 00191072195661 ()


  • General surgical procedure kit, non-medicated, single-use
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