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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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WA Holter System - 90815187020283

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

  • 90815187020283 ()
402811

  • Electrocardiographic ambulatory recorder

WA Holter System - 90815187020276

HR100 Holter Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR100
In Commercial Distribution

  • 90815187020276 ()
402810

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094008920

PROBP 3400 STANDARD EXCHANGE
WELCH ALLYN, INC.
901055
In Commercial Distribution

  • 00732094008920 ()
34XX-EX

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Piccolo Composite Nailing System - 07290109338781

Exchange Tube for use with the Piccolo Composite Proximal Femur Nailing System
CARBOFIX ORTHOPEDICS LTD
Exchange Tube
In Commercial Distribution

  • 07290109338781 ()
PFT912240

  • Orthopaedic implantation sleeve, single-use

Piccolo Composite Nailing System - 07290109339948

Exchange Tube for use with the Piccolo Composite Proximal Femur Nailing System
CARBOFIX ORTHOPEDICS LTD
Exchange Tube
In Commercial Distribution

  • 07290109339948 ()
PFT912240L

  • Orthopaedic implantation sleeve, single-use

COBE® Spectra - 05020583707009

Red Blood Cell Exchange Set
TERUMO BCT, INC.
70700
In Commercial Distribution

  • 05020583707009 ()
  • 35020583707000 ()
70700

  • Blood transfer set

Heat Moisture Exchanger - 00848530083274

Heat Moisture Exchange Large Volume
SUNSET HEALTHCARE SOLUTIONS, INC.
RES027IL
In Commercial Distribution

  • 00848530083274 ()


  • Heat/moisture exchanger, single-use

Exchange Select One Step Pregnancy Test - 00614299396425

FPPL Exchange Select DPS +/- (ER)
SPD SWISS PRECISION DIAGNOSTICS GMBH
FPPL
In Commercial Distribution

  • 00614299396425 ()
  • 10614299396422 ()
  • 00633472000133 ()


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

Centurion - 00653160237771

ARTERIAL LINE INSERTION/EXCHANGE KIT
CENTURION MEDICAL PRODUCTS CORPORATION
CVI3370
In Commercial Distribution

  • 10653160237778 ()
  • 00653160237771 ()
CVI3370

  • Arterial blood sampling kit

Diapact® - 04039239047346

Plasma Exchange (PEX) Tubing Set
B. BRAUN MEDICAL INC.
7210518
Not in Commercial Distribution

  • 04039239047346 ()
  • 04039239047339 ()
7210518

  • Apheresis system tubing set
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