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
Alung Technologies, Inc.
40600
Not in Commercial Distribution

  • 00850046004278 ()


  • Mobile extracorporeal gas exchange system
Hemolung® Cartridge with Blood Tubing
Alung Technologies, Inc.
40400
Not in Commercial Distribution

  • 00850046004254 ()


  • Mobile extracorporeal gas exchange system
Hemolung® Rinse Back Kit
Alung Technologies, Inc.
40300
Not in Commercial Distribution

  • 00850046004247 ()


  • Mobile extracorporeal gas exchange system
Hemolung® Accessories Kit
Alung Technologies, Inc.
40200
Not in Commercial Distribution

  • 00850046004230 ()


  • Mobile extracorporeal gas exchange system
Hemolung® Cartridge Kit
Alung Technologies, Inc.
40100
Not in Commercial Distribution

  • 00850046004223 ()


  • Mobile extracorporeal gas exchange system
Hemolung® CR4 Controller
Alung Technologies, Inc.
21000
Not in Commercial Distribution

  • 00850046004056 ()


  • Mobile extracorporeal gas exchange system
Rocket AmniocentesIs Exchange Set
ROCKET MEDICAL PLC
R57035
In Commercial Distribution

  • 05055270942623 ()
  • 05055270921239 ()
  • 05055270964021 ()

  • Length: 17.0 Centimeter
  • Outer Diameter: 1.473 Millimeter
R57035

  • Chorionic villus sampling needle
Therapeutic Plasma Exchange Set
TERUMO BCT, INC.
70500
In Commercial Distribution

  • 05020583705005 ()
  • 35020583705006 ()
70500

  • Blood transfer set
LIPID LINE EXCHANGE KIT
MEDLINE INDUSTRIES, INC.
LC435
In Commercial Distribution

  • 10193489455557 ()
  • 40193489455558 ()
LC435

  • General surgical procedure kit, non-medicated, single-use
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
NEONATAL EXCHANGE TRANSFUSION TRAY
APOLLO MEDICAL PRODUCTS CORP.
ETT-NW
In Commercial Distribution

  • 10685404001777 ()
  • 00685404001770 ()


  • General surgical procedure kit, medicated
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
Air/Fluid Exchange Line
SYNERGETICS USA, INC.
17680
In Commercial Distribution

  • 20841305107803 ()
  • 10841305101323 ()
17680

  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
HR300 Holter Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020283 ()
402811

  • Electrocardiographic ambulatory recorder
HR100 Holter Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR100
In Commercial Distribution

  • 90815187020276 ()
402810

  • Electrocardiographic ambulatory recorder
Exchange Pin, Stainless Steel
Life Spine, Inc.
152-103
In Commercial Distribution

  • 00190837062644 ()
152-103

  • Spinal intraoperative positioning pin, single-use
RUSSELL-TAYLOR MEDULLARY EXCHANGE TUBE-DISPOSABLE
Smith & Nephew, Inc.
415113
In Commercial Distribution

  • 03596010122858 ()
415113

  • Orthopaedic inorganic implant inserter/extractor, reusable
Soft-Tipped Extra-Firm Exchange Catheter
COOK INCORPORATED
G36402
In Commercial Distribution

  • 00827002364028 ()
C-CAE-14.0-100-DLT-EF-ST

  • Endotracheal tube guide, single-use
Soft-Tipped Extra-Firm Exchange Catheter
COOK INCORPORATED
G36401
In Commercial Distribution

  • 00827002364011 ()
C-CAE-11.0-100-DLT-EF-ST

  • Endotracheal tube guide, single-use
Weinmann Tracheostomy Exchange Set
COOK INCORPORATED
G31447
In Commercial Distribution

  • 00827002314474 ()
C-PTIS-100-HC-EXCH

  • Tracheostomy kit, single-use
G-J TUBE EXCHANGE TRAY
AMERICAN CONTRACT SYSTEMS, INC.
MCGJ15A
In Commercial Distribution

  • 00191072195661 ()


  • General surgical procedure kit, non-medicated, single-use
GUIDE WIRE EXCHANGE TUBE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568034172 ()
17353

  • General internal orthopaedic fixation system implantation kit
HUMERAL WIRE EXCHANGE TUBE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568039740 ()
178353

  • General internal orthopaedic fixation system implantation kit
TORQ TNT Exchange Tube
Si-Bone Inc.
501775
In Commercial Distribution

  • 00810055523719 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
PROBP 3400 STANDARD EXCHANGE
WELCH ALLYN, INC.
901055
In Commercial Distribution

  • 00732094008920 ()
34XX-EX

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Arndt Airway Exchange Catheter
COOK INCORPORATED
G11920
In Commercial Distribution

  • 00827002119208 ()
C-CAE-14.0-70-LMA

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter
COOK INCORPORATED
G07873
In Commercial Distribution

  • 00827002078734 ()
C-CAE-14.0-83

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter
COOK INCORPORATED
G07833
In Commercial Distribution

  • 00827002078338 ()
C-CAE-8.0-45

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter
COOK INCORPORATED
G06732
In Commercial Distribution

  • 00827002067325 ()
C-CAE-11.0-83

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter
COOK INCORPORATED
G05880
In Commercial Distribution

  • 00827002058804 ()
C-CAE-19.0-83

  • Endotracheal tube guide, single-use
14 Exchange Hydrophilic Guidewire
Micro Therapeutics, Inc.
103-0602-350
In Commercial Distribution

  • 00836462003255 ()

  • Length: 350 Centimeter
  • Guidewire,.014,Inch;
103-0602-350

  • Cardiac/peripheral vascular guidewire, single-use
10 Exchange Hydrophilic Guidewire
Micro Therapeutics, Inc.
103-0601-350
In Commercial Distribution

  • 00836462003248 ()

  • Length: 350 Centimeter
  • Guidewire,.010,Inch;
103-0601-350

  • Cardiac/peripheral vascular guidewire, single-use
14 Exchange Hydrophilic Guidewire
Micro Therapeutics, Inc.
103-0602-300
In Commercial Distribution

  • 00836462003071 ()

  • Length: 300 Centimeter
  • Guidewire,.014,Inch;
103-0602-300

  • Cardiac/peripheral vascular guidewire, single-use
10 Exchange Hydrophilic Guidewire
Micro Therapeutics, Inc.
103-0601-300
In Commercial Distribution

  • 00836462003026 ()

  • Length: 300 Centimeter
  • Guidewire,.010,Inch;
103-0601-300

  • Cardiac/peripheral vascular guidewire, single-use
Exchange Pin – 2.0 mm
Si-Bone Inc.
500091
In Commercial Distribution

  • 00855369008101 ()


  • Orthopaedic bone pin, non-bioabsorbable
Exchange Pin – 3.2 mm
Si-Bone Inc.
500090
In Commercial Distribution

  • 00855369008095 ()


  • Orthopaedic bone pin, non-bioabsorbable
Exchange Pin – 2.0 mm
Si-Bone Inc.
500378
In Commercial Distribution

  • 00855369008064 ()


  • Orthopaedic bone pin, non-bioabsorbable
Exchange Pin – 3.2 mm
Si-Bone Inc.
500375
In Commercial Distribution

  • 00855369008033 ()


  • Orthopaedic bone pin, non-bioabsorbable
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
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
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
Heat Moisture Exchange Large Volume
SUNSET HEALTHCARE SOLUTIONS, INC.
RES027IL
In Commercial Distribution

  • 00848530083274 ()


  • Heat/moisture exchanger, single-use
Red Blood Cell Exchange Set
TERUMO BCT, INC.
70700
In Commercial Distribution

  • 05020583707009 ()
  • 35020583707000 ()
70700

  • Blood transfer set
ARTERIAL LINE INSERTION/EXCHANGE KIT
CENTURION MEDICAL PRODUCTS CORPORATION
CVI3370
In Commercial Distribution

  • 10653160237778 ()
  • 00653160237771 ()
CVI3370

  • Arterial blood sampling kit
CUSTOM PACK BB10M30R1 OXY EXCHANGE
MEDTRONIC, INC.
BB10M30R1
In Commercial Distribution

  • 00199150014606 ()


  • Cardiopulmonary bypass system blood tubing set
Needle Driver and Anchor Exchange
Apollo Endosurgery, Inc.
ESS-G02-NXT
In Commercial Distribution

  • 00811955020896 ()
  • 10811955020893 ()
ESS-G02-NXT

  • Suturing unit, single-use
Needle Driver and Anchor Exchange
Apollo Endosurgery, Inc.
ESS-ESG-NXT
In Commercial Distribution

  • 00811955020834 ()
ESS-ESG-NXT

  • Suturing unit, single-use
Palay IOL Exchange Cannu/Formed
Psi/Eye-Ko, Inc.
Rx9500
In Commercial Distribution

  • 00840516133515 ()
  • 00840516135052 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Eickmann Implant Remover 8mm Exchange
INNOMED, INC.
5475-08-E
In Commercial Distribution

  • 00840277124234 ()
5475-08-E

  • Orthopaedic osteotome
144 Volt 22.0Ah SLA - Exchange
R & D Batteries, Inc.
6453
In Commercial Distribution

  • 00810149096136 ()


  • Portable/mobile rechargeable battery pack
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