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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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Shur-Clens - 10860006476035

Case of 24 Containers of Sterile Sodium Chloride 0.9%, USP in 120 mL BFS Container.
Asept Pak, Inc.
980093
In Commercial Distribution

  • 00860006476038 ()
  • 10860006476035 ()


  • Pressure-regulated wound irrigation solution applicator, manual

Corning - H108118121

Corning 1L Polycarbonate Erlenmeyer, w/ ATC, S, Silicone Tubing sz. 24 1/bag, 4/case
Corning Incorporated
11812
In Commercial Distribution

  • H108118123 ()
  • H108118121 ()
11812

  • Blood/tissue storage/culture container

CUTFIX - 04038653865086

CUTFIX Disposable Scalpel, polymer handle, Fig. 24, stainless steel, sterile, disposable, package of 10 pieces
Aesculap AG
5518091
In Commercial Distribution

  • 04038653472734 ()
  • 04038653865086 ()
  • 04045439038633 ()
5518091

  • Scalpel, single-use

ICU Medical - 00840619039578

Transpac™ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP)
ICU MEDICAL, INC.
42586-05
In Commercial Distribution

  • 10840619039575 ()
  • 00840619039578 ()
42586-05

  • Invasive blood pressure transducer set

ICU Medical - 00887709075320

82" Trifuse 15 Drop 24 Hour Admin Set w/Inj Site, Bravo24®, Rotating Luer
ICU MEDICAL, INC.
B99322
In Commercial Distribution

  • 10887709075327 ()
  • 00887709075320 ()


  • Basic intravenous administration set, noninvasive

TandemLife LifeSPARC - 00814112020708

LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5840-2415
Not in Commercial Distribution

  • 00814112020708 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

TandemLife LifeSPARC - 00814112020692

LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5840-2417
Not in Commercial Distribution

  • 00814112020692 ()


  • Cardiopulmonary bypass system centrifugal pump
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system mounting unit
  • Vascular dilator, single-use
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

ICU Medical - 00887709056824

139" 15 Drop 24 Hour Primary Set w/4 Bravo24®, 3-Way Stopcock, Rotating Luer
ICU MEDICAL, INC.
B99256
In Commercial Distribution

  • 10887709056821 ()
  • 00887709056824 ()


  • Basic intravenous administration set, noninvasive

ICU Medical - 00887709123311

Transpac™ IT MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP)
ICU MEDICAL, INC.
42800-24
In Commercial Distribution

  • 10887709123318 ()
  • 00887709123311 ()
42800-24

  • Invasive blood pressure transducer set

ICU Medical - 00887709120785

Transpac IT Monitoring Kit, 24" Safeset Reservoir, Blood Sampling Port, 3ml Flush Device, Un-Bonded Macrodrip
ICU MEDICAL, INC.
42801-29
In Commercial Distribution

  • 10887709120782 ()
  • 00887709120785 ()
42801-29

  • Invasive blood pressure transducer set
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