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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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MC3 Crescent(tm) Jugular Dual Lumen Catheter 24 FR - 10854916006918

Jugular Dual Lumen Catheter 24 FR, CE Mark
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70124
In Commercial Distribution


  • Catheter Gauge: 24 French
70124

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Opus(tm) Vascular Access Kit - 10854916006833

Vascular Access Kit
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
21030
In Commercial Distribution

  • 10854916006833 ()
  • 20854916006847 ()
21030

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006819

Dual Lumen ECMO Cannula
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70130
In Commercial Distribution

  • 10854916006819 ()

  • Catheter Gauge: 30 French
70130

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006802

Dual Lumen ECMO Cannula
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70128
In Commercial Distribution

  • 10854916006802 ()

  • Catheter Gauge: 28 French
70128

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006796

Dual Lumen ECMO Cannula
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70126
In Commercial Distribution

  • 10854916006796 ()

  • Catheter Gauge: 26 French
70126

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006789

Dual Lumen ECMO Cannula
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70124
In Commercial Distribution

  • 10854916006789 ()

  • Catheter Gauge: 24 French
70124

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 19FR - 10850007732537

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70419
In Commercial Distribution

  • 10850007732537 ()
70419

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 24FR - 10850007732230

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
71824
In Commercial Distribution

  • 10850007732230 ()
71824

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 15FR - 10850007732520

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70415
In Commercial Distribution

  • 10850007732520 ()
70415

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 13FR - 10850007732513

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70413
In Commercial Distribution

  • 10850007732513 ()
70413

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 19FR - 10850007732223

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70419
In Commercial Distribution

  • 10850007732223 ()
70419

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 15FR - 10850007732216

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70415
In Commercial Distribution

  • 10850007732216 ()
70415

  • Mobile extracorporeal gas exchange system catheter kit

MC3 Crescent RA Dual Lumen Catheter 13FR - 10850007732209

The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
70413
In Commercial Distribution

  • 10850007732209 ()
70413

  • Mobile extracorporeal gas exchange system catheter kit

ProtekDuo - 00814112020319

31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer
CARDIACASSIST, INC.
5140-5131
In Commercial Distribution

  • 00814112020319 ()


  • Mobile extracorporeal gas exchange system catheter kit

PROTEK Duo - 00814112020166

29 Fr x 46 cm veno-venous dual lumen cannula with introducer
CARDIACASSIST, INC.
5140-4629
In Commercial Distribution

  • 00814112020166 ()


  • Mobile extracorporeal gas exchange system catheter kit

ProtekDuo - 00814112020531

31 Fr x 36 cm Dual Lumen VV Cannula Set
CARDIACASSIST, INC.
5140-3631
Not in Commercial Distribution

  • 00814112020531 ()


  • Mobile extracorporeal gas exchange system catheter kit

PROTEK DUO+ - 08033178019460

No Description
SORIN GROUP ITALIA SRL
5100-3118
In Commercial Distribution

  • 08033178019460 ()


  • Mobile extracorporeal gas exchange system catheter kit

PROTEK DUO+ - 08033178019453

No Description
SORIN GROUP ITALIA SRL
5100-2916
In Commercial Distribution

  • 08033178019453 ()


  • Mobile extracorporeal gas exchange system catheter kit

PROTEK DUO+ - 08033178019422

No Description
SORIN GROUP ITALIA SRL
5150-5131
In Commercial Distribution

  • 08033178019422 ()


  • Mobile extracorporeal gas exchange system catheter kit

PROTEK DUO+ - 08033178019392

No Description
SORIN GROUP ITALIA SRL
5150-4629
In Commercial Distribution

  • 08033178019392 ()


  • Mobile extracorporeal gas exchange system catheter kit

Catheter w/ Blunt Introducer - 10816203022148

ECMO Reinforced Dual Lumen Cannula, 32F
ORIGEN BIOMEDICAL, INC.
VV32F
Not in Commercial Distribution

  • 10816203022148 ()


  • Mobile extracorporeal gas exchange system catheter kit

Catheter w/ Blunt Introducer - 10816203022100

ECMO Reinforced Dual Lumen Cannula, 23F
ORIGEN BIOMEDICAL, INC.
VV23F
Not in Commercial Distribution

  • 10816203022100 ()


  • Mobile extracorporeal gas exchange system catheter kit

Catheter w/ Blunt Introducer - 10816203022094

ECMO Reinforced Dual Lumen Cannula, 19F
ORIGEN BIOMEDICAL, INC.
VV19F
Not in Commercial Distribution

  • 10816203022094 ()


  • Mobile extracorporeal gas exchange system catheter kit

Catheter w/ Blunt Introducer - 10816203022070

ECMO Reinforced Dual Lumen Cannula, 16F
ORIGEN BIOMEDICAL, INC.
VV16F
Not in Commercial Distribution

  • 10816203022070 ()


  • Mobile extracorporeal gas exchange system catheter kit

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

Anodyne Surgical - 00840516110479

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

  • 00840516106700 ()
  • 00840516110479 ()


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

WA Holter System - 90815187020290

HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder

Scanner S300 - D800ERAB4061

Scanner S300 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4061
In Commercial Distribution

  • D800ERAB4061 ()


  • Dental milling system, CAD/CAM, laboratory

Scanner S900 - D800ERAB4051

Scanner S900 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4051
In Commercial Distribution

  • D800ERAB4051 ()


  • Dental milling system, CAD/CAM, laboratory

Surgical Direct - B382SD101790

11mm Trocar Screw Shaft for Exchange
Surgical Direct, Inc.
SD10179
In Commercial Distribution

  • B382SD101790 ()

  • Outer Diameter: 11 Millimeter
SD10179

  • Endoscope sheath, reusable

TranS1 - 00815361020297

AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire
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