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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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Catheter w/ Blunt Introducer - 10816203022124

ECMO Reinforced Dual Lumen Cannula, 28F
ORIGEN BIOMEDICAL, INC.
VV28F
Not in Commercial Distribution

  • 10816203022124 ()


  • Mobile extracorporeal gas exchange system catheter kit

Catheter w/ Blunt Introducer - 10816203022056

ECMO Reinforced Dual Lumen Cannula, 13F
ORIGEN BIOMEDICAL, INC.
VV13F
Not in Commercial Distribution

  • 10816203022056 ()


  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006826

Dual Lumen ECMO Cannula
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70132
In Commercial Distribution

  • 10854916006826 ()

  • Catheter Gauge: 32 French
70132

  • Mobile extracorporeal gas exchange system catheter kit

CrossFAST™ Integrated Microcatheter Advanced Delivery System - 00860007727917

5.5, Catheter with Rapid Exchange Length
Vantis Vascular, Inc.
CFM55
In Commercial Distribution

  • 00860007727917 ()
  • 20860007727911 ()


  • Vascular guide-catheter, single-use

Hemoglobin Variants System - 00847817007163

Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817007163 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent

Hemoglobin Variants System - 00847817006791

Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817006791 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent

Exchange Select Early Result Pregnancy Test - 00614299402676

PLPL Exchange Select DPS Early Result
SPD SWISS PRECISION DIAGNOSTICS GMBH
PLPL
In Commercial Distribution

  • 00614299402676 ()
  • 10614299402673 ()
  • 00633472000126 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

JBC - 04719871892251

Heat And Moisture Exchange Filters (HMEF)
FOREMOUNT ENTERPRISE CO., LTD.
400-1046/25
In Commercial Distribution

  • 04719871892251 ()


  • Heat/moisture exchanger/microbial medical gas filter

BALLARD* 1000 Heat and Moisture Exchange Filter - 00609038938219

1000 Heat and Moisture Exchange Filter
Avanos Medical, Inc.
93821
In Commercial Distribution

  • 10609038938216 ()
  • 00609038938219 ()
157

  • Heat/moisture exchanger, single-use

Anodyne Surgical - 00840516118208

[Palay] IOL Exchange Cannula 30g, formed
Psi/Eye-Ko, Inc.
9500
In Commercial Distribution

  • 00840516122069 ()
  • 00840516118208 ()
  • 00840516125930 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
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