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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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Ultra PC % Cabinet Mount Package G - 00813830022650

No Description
ACCUTRON, INC.
36600
In Commercial Distribution

  • 00813830022650 ()
36600

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC % Package U - 00813830022643

No Description
ACCUTRON, INC.
36500-US
In Commercial Distribution

  • 00813830022643 ()
36500-US

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC % Package F - 00813830022605

No Description
ACCUTRON, INC.
36500
In Commercial Distribution

  • 00813830022605 ()
36500

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC % Package E - 00813830022568

No Description
ACCUTRON, INC.
36400
In Commercial Distribution

  • 00813830022568 ()
36400

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC % Package D - 00813830022520

No Description
ACCUTRON, INC.
36300
In Commercial Distribution

  • 00813830022520 ()
36300

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC % Package C - 00813830022490

No Description
ACCUTRON, INC.
36200
In Commercial Distribution

  • 00813830022490 ()
36200

  • Oxygen/air/nitrous oxide breathing gas mixer

Small Multi Use Non Scavenger Cir - 00813830021530

No Description
ACCUTRON, INC.
33013-A
Not in Commercial Distribution

  • 00813830021530 ()
33013-A

  • Oxygen/air/nitrous oxide breathing gas mixer

Med Multi Use Non Scavenger Cir - 00813830021516

No Description
ACCUTRON, INC.
33012-A
Not in Commercial Distribution

  • 00813830021516 ()
33012-A

  • Oxygen/air/nitrous oxide breathing gas mixer

Large Multi Use Non Scavenger Cir - 00813830021493

No Description
ACCUTRON, INC.
33011-A
Not in Commercial Distribution

  • 00813830021493 ()
33011-A

  • Oxygen/air/nitrous oxide breathing gas mixer

Non-Scavenging Circuit - 00813830021462

No Description
ACCUTRON, INC.
33010-A
Not in Commercial Distribution

  • 00813830021462 ()
33010-A

  • Oxygen/air/nitrous oxide breathing gas mixer

Alpha III flowmeter - Medical Gas - 00813830021233

No Description
ACCUTRON, INC.
32000-MG
Not in Commercial Distribution

  • 00813830021233 ()
32000-MG

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra DC Flowmeter - 00813830021219

No Description
ACCUTRON, INC.
31980
In Commercial Distribution

  • 00813830021219 ()
31980

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC% Flowmeter - 00813830021158

No Description
ACCUTRON, INC.
31975
In Commercial Distribution

  • 00813830021158 ()
31975

  • Oxygen/air/nitrous oxide breathing gas mixer

Flowmeter, CM - 00813830021141

No Description
ACCUTRON, INC.
31970
In Commercial Distribution

  • 00813830021141 ()
31970

  • Oxygen/air/nitrous oxide breathing gas mixer

FRU, Extension, Oxygen Liter/Flowmeter - 00813830021134

No Description
ACCUTRON, INC.
27429
Not in Commercial Distribution

  • 00813830021134 ()
27429

  • Oxygen/air/nitrous oxide breathing gas mixer

FRU, WAGD Vacuum Hose - 00813830021103

No Description
ACCUTRON, INC.
27397
Not in Commercial Distribution

  • 00813830021103 ()
27397

  • Oxygen/air/nitrous oxide breathing gas mixer

FRU, PC N2O Lock Plug - 00813830021004

No Description
ACCUTRON, INC.
27236
In Commercial Distribution

  • 00813830021004 ()
27236

  • Oxygen/air/nitrous oxide breathing gas mixer

Flowmeter, CM assembly - 00813830020960

No Description
ACCUTRON, INC.
27150
Not in Commercial Distribution

  • 00813830020960 ()
27150

  • Oxygen/air/nitrous oxide breathing gas mixer

Flowmeter, Digital Flushmount - 00813830020885

No Description
ACCUTRON, INC.
27076
In Commercial Distribution

  • 00813830020885 ()
27076

  • Oxygen/air/nitrous oxide breathing gas mixer

Flowmeter, Digital FlexMount - 00813830020694

No Description
ACCUTRON, INC.
26400
Not in Commercial Distribution

  • 00813830020694 ()
26400

  • Oxygen/air/nitrous oxide breathing gas mixer

Kit, Accessories, CM/RFS - 00813830020588

No Description
ACCUTRON, INC.
26227
In Commercial Distribution

  • 00813830020588 ()
26227

  • Oxygen/air/nitrous oxide breathing gas mixer

FRU, Remote Bagtee Chair Mount - 00813830020359

No Description
ACCUTRON, INC.
25042
Not in Commercial Distribution

  • 00813830020359 ()
25042

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer Low Flow 15LPM - 04251411700928

Oxymixer blender Low Flow with 15LPM Flowmeter
DEHAS Medical Systems GmbH
Low Flow 15LPM
In Commercial Distribution

  • 04251411700928 ()
MP04229

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer Low Flow SET - 04251411700027

Oxymixer blender Low Flow SET
DEHAS Medical Systems GmbH
Low Flow SET
In Commercial Distribution

  • 04251411700027 ()
MP04203

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer Configuration - 04251411700935

Oxymixer blender configurable with blender Low Flow or High Flow blender version.
DEHAS Medical Systems GmbH
Configuration
In Commercial Distribution

  • 04251411700935 ()
MP04200

  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer XL Low Flow - 04251411700775

Oxymixer XL blender Low Flow
DEHAS Medical Systems GmbH
XL Low Flow
In Commercial Distribution

  • 04251411700775 ()


  • Oxygen/air/nitrous oxide breathing gas mixer

Oxymixer High Flow SET - 04251411700010

Oxymixer blender High Flow SET
DEHAS Medical Systems GmbH
High Flow SET
In Commercial Distribution

  • 04251411700010 ()
MP04201

  • Oxygen/air/nitrous oxide breathing gas mixer

2008® Series Hemodialysis Machines - 00840861100965

2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Fresenius Usa, Inc.
190904
In Commercial Distribution

  • 00840861100965 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100958

2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
Fresenius Usa, Inc.
190395
In Commercial Distribution

  • 00840861100958 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100941

2008K@HOME HEMODIALYSIS SYSTEM
Fresenius Usa, Inc.
190828
In Commercial Distribution

  • 00840861100941 ()


  • Haemodialysis system, institutional/home-use

2008® Series Hemodialysis Machines - 00840861100934

2008T HD SYSTEM WITH CDX, CANADA
Fresenius Usa, Inc.
190908
In Commercial Distribution

  • 00840861100934 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100927

2008T GEN 2 BIBAG WITHOUT CDX
Fresenius Usa, Inc.
190895
In Commercial Distribution

  • 00840861100927 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100910

2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG
Fresenius Usa, Inc.
190766
In Commercial Distribution

  • 00840861100910 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100903

2008T HEMODIALYSIS SYSTEM WITHOUT CDX
Fresenius Usa, Inc.
190858
In Commercial Distribution

  • 00840861100903 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100897

2008T HEMODIALYSIS SYS., with CDX
Fresenius Usa, Inc.
190713
In Commercial Distribution

  • 00840861100897 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100873

2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE
Fresenius Usa, Inc.
190633
In Commercial Distribution

  • 00840861100873 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100866

2008K2 MACHINE, SHORT CAB, OLC/DP, HP
Fresenius Usa, Inc.
190630
In Commercial Distribution

  • 00840861100866 ()


  • Haemodialysis system, institutional

2008® Series Hemodialysis Machines - 00840861100859

2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS
Fresenius Usa, Inc.
190610
In Commercial Distribution

  • 00840861100859 ()


  • Haemodialysis system, institutional

CIM med GmbH - 04061162078937

Support arm Pivot grounded 300, adapter for Cerner, adapter anaesthesia machines with side channel
CIM med GmbH
A-230CN1-4K.bl1
Not in Commercial Distribution

  • 04061162078937 ()


  • Medical monitor/light mount

CIM med GmbH - 04061162082422

Support arm Pivot grounded 240, adapter for Cerner, adapter anaesthesia machines with side channel
CIM med GmbH
A-224CN1-4K.gr1
Not in Commercial Distribution

  • 04061162082422 ()


  • Medical monitor/light mount

CIM med GmbH - 04061162037149

Flush Mount, VESA 75/100, adapter anaesthesia machines with side channel
CIM med GmbH
S-910G-4K.gr1
Not in Commercial Distribution

  • 04061162037149 ()


  • Medical monitor/light mount

CPAP Filter - 00848530105136

Replacement Standard Filter - 6/Pack Resmed S9/Airsense 10 CPAP Machines
SUNSET HEALTHCARE SOLUTIONS, INC.
F-114-6
In Commercial Distribution

  • 00848530105136 ()


  • CPAP/BPAP unit ambient air filter, reusable

DIASOL - B467CAG50

Citric Acid 50%. Liquid concentrate for the cleaning, decalcification and heat disinfections of hemodialysis machines.
DIASOL, INC.
CAG50
In Commercial Distribution

  • B467CAG504 ()
  • B467CAG50 ()
CAG23

  • Haemodialysis concentrate

DIASOL - B467AA6

Acetic Acid 6%. Liquid concentrate for the cleaning, decalcification and heat disinfections of hemodialysis machines.
DIASOL, INC.
AA6
In Commercial Distribution

  • B467AA64 ()
  • B467AA6 ()
AA624

  • Haemodialysis concentrate

CPAP Filter - 00848530104825

REPLACEMENT REUSABLE FOAM FILTER Apex XT, ComfortPAP, PureSom and ZzzPAP CPAP Machines
SUNSET HEALTHCARE SOLUTIONS, INC.
F-136-1
In Commercial Distribution

  • 00848530104825 ()


  • CPAP/BPAP unit ambient air filter, reusable

SIUI - 06938396497002

CR Series Trolley, CR Series Cart, used to transport medical ultrasound machines.
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CR-30A
In Commercial Distribution

  • 06938396497002 ()


  • Instrument trolley

Vive - 00810113577593

Achilles Wedge (Large)
VIVE HEALTH LLC
SUP3070BLKL
In Commercial Distribution

  • 10810113577590 ()
  • 00810113577593 ()


  • Geometric shape exerciser

Vive - 00810113577586

Achilles Wedge (Medium)
VIVE HEALTH LLC
SUP3070BLKM
In Commercial Distribution

  • 10810113577583 ()
  • 00810113577586 ()


  • Geometric shape exerciser

Vive - 00810113577579

Achilles Wedge (Small)
VIVE HEALTH LLC
SUP3070BLKS
In Commercial Distribution

  • 10810113577576 ()
  • 00810113577579 ()


  • Geometric shape exerciser

Angel Whole Blood Processing System Machine - EU - Reworked - 00852714003088

Angel Whole Blood Processing System Machine - EU - Reworked with 020162 EU Case Label for Refurbished Machines
NUO THERAPEUTICS INC
976000901
In Commercial Distribution

  • 00852714003088 ()


  • Apheresis system
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