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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No Description
VARIAN MEDICAL SYSTEMS, INC.
1.6
In Commercial Distribution

  • 00899475002264 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.7
In Commercial Distribution

  • 00899475002202 ()


  • Real-time position management respiratory gating system, optical
Gating Module for Siemens 4D-CT
DYN'R
1.0
Not in Commercial Distribution

  • 03615070000408 ()
SDX0361V1.0

  • Real-time position management respiratory gating system, optical
Gating Module for Probeam
DYN'R
1.0
Not in Commercial Distribution

  • 03615070000903 ()
SDX0365V1.0

  • Real-time position management respiratory gating system, optical
Description: 2% ENFLURANE, BAL. N2; Cylinder: XL; Valve: CGA 510; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601020429 ()

  • Total Volume: 54 Liter
  • Pressure: 398 Pound per Square Inch
Z02NI98M350Y050

  • Carbon monoxide breath analyser
Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: EL; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
AIRGAS USA LLC
Pulmonary Function Gas
In Commercial Distribution

  • 00819601020412 ()

  • Total Volume: 620 Liter
  • Pressure: 2000 Pound per Square Inch
Z04NI685EA0033

  • Carbon monoxide breath analyser
Description: 0.3% CO18, 0.6% C2H2, 9% He, 45% O2, Bal. N2; Cylinder: H; Valve: CGA 296; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
AIRGAS USA LLC
Pulmonary Function Gas
In Commercial Distribution

  • 00819601020405 ()

  • Total Volume: 1115 Liter
  • Pressure: 370 Pound per Square Inch
Z05NI458200C000

  • Carbon monoxide breath analyser
Description: 0.3% CO18, 10% He, 35% O2, Bal. N2; Cylinder: AG 80; Valve: CGA 296; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
AIRGAS USA LLC
Pulmonary Function Gas
In Commercial Distribution

  • 00819601020399 ()

  • Total Volume: 1578 Liter
  • Pressure: 1450 Pound per Square Inch
Z04NI54M80C000

  • Carbon monoxide breath analyser
Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
AIRGAS USA LLC
Device Gas
In Commercial Distribution

  • 00819601020047 ()
Lung Diffusion Gas

  • Carbon monoxide breath analyser
No Description
FIM MEDICAL
V2
In Commercial Distribution

  • 03760253450294 ()


  • Carbon monoxide breath analyser
NAV1-Module
Karl Storz GmbH & Co. KG
40810020
In Commercial Distribution

  • 04048551291030 ()


  • Optical surgical navigation device tracking system workstation, stationary
CAPNOSTAT Sampling Airway Adapter with Tubing
Carefusion Finland 320 Oy
412343-002
Not in Commercial Distribution

  • 10885403257025 ()
412343-002

  • Carbon dioxide cuvette, reusable
CAPNOSTAT Pediatric/Infant Airway Adapter, Reusable
Carefusion Finland 320 Oy
412342-001
Not in Commercial Distribution

  • 10885403257018 ()
412342-001

  • Carbon dioxide cuvette, reusable
CAPNOSTAT Adult/Pediatric Ai rway Adapter, Reusable
Carefusion Finland 320 Oy
412341-001
Not in Commercial Distribution

  • 10885403257001 ()
412341-001

  • Carbon dioxide cuvette, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
4714437
In Commercial Distribution

  • 04049098009195 ()


  • Carbon dioxide cuvette, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
4721788
In Commercial Distribution

  • 04049098009072 ()


  • Carbon dioxide cuvette, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
4721796
In Commercial Distribution

  • 04049098009065 ()


  • Carbon dioxide cuvette, reusable
Optical Navigation Probe
Karl Storz GmbH & Co. KG
40800110
In Commercial Distribution

  • 04048551161005 ()


  • Optical surgical navigation device tracking system workstation, stationary
RE-USEABLE AIRWAY ADAPTER,NEO/PED
Carefusion Corporation
16608
Not in Commercial Distribution

  • 10846446000993 ()
16608

  • Carbon dioxide cuvette, reusable
MicroCO
Jaeger Medical GmbH
36-MC02-STK
Not in Commercial Distribution

  • 54250892901362 ()
36-MC02-STK

  • Carbon monoxide breath analyser
SmokeCheck
CAREFUSION U.K. 232 LIMITED
36-SC01-STK
Not in Commercial Distribution

  • 54250892980145 ()
36-SC01-STK

  • Carbon monoxide breath analyser
MicroCO
CAREFUSION U.K. 232 LIMITED
36-MC02-STK
Not in Commercial Distribution

  • 54250892980015 ()
36-MC02-STK

  • Carbon monoxide breath analyser
MicroCO
Jaeger Medical GmbH
36-MC02-STK
In Commercial Distribution

  • 54250892905506 ()
36-MC02-STK

  • Carbon monoxide breath analyser
SmokeCheck
Jaeger Medical GmbH
36-SC01-STK
Not in Commercial Distribution

  • 54250892901584 ()
36-SC01-STK

  • Carbon monoxide breath analyser
BREATHCO MONITOR
VITALOGRAPH (IRELAND) LIMITED
2900
In Commercial Distribution

  • 05099169297500 ()
  • 15099169297507 ()


  • Carbon monoxide breath analyser
MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA2000
In Commercial Distribution

  • 14250892904136 ()
36-PSA2000

  • Carbon monoxide breath analyser
Mouthpiece Adaptor
Jaeger Medical GmbH
36-PSA1800
In Commercial Distribution

  • 14250892904129 ()
36-PSA1800

  • Carbon monoxide breath analyser
MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA2000
Not in Commercial Distribution

  • 14250892901838 ()
36-PSA2000

  • Carbon monoxide breath analyser
MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA1800
Not in Commercial Distribution

  • 14250892901869 ()
36-PSA1800

  • Carbon monoxide breath analyser
Neonatal Airway Adapter
Respironics Novametrix, LLC
7053-01
In Commercial Distribution

  • 00884838014077 ()
7053-01

  • Carbon dioxide cuvette, reusable
Pediatric/Adult Airway Adapter
Respironics Novametrix, LLC
7007-01
In Commercial Distribution

  • 00884838014060 ()
7007-01

  • Carbon dioxide cuvette, reusable
Pediatric/Adult Airway Adapter
Respironics Novametrix, LLC
1149450
In Commercial Distribution

  • 00884838104808 ()
1149450

  • Carbon dioxide cuvette, reusable
Neonatal Airway Adapter
Respironics Novametrix, LLC
1149465
In Commercial Distribution

  • 00884838104716 ()
1149465

  • Carbon dioxide cuvette, reusable
Adult Airway Adapter
Respironics Novametrix, LLC
1149447
In Commercial Distribution

  • 00884838104709 ()
1149447

  • Carbon dioxide cuvette, reusable
Reusable Infant Airway Adapter
Philips Medizin Systeme Böblingen GmbH
Reusable Infant Airway Adapter
Not in Commercial Distribution

  • 00884838072169 ()
989803142691

  • Carbon dioxide cuvette, reusable
Neonatal Airway Adapter
Respironics Novametrix, LLC
1149958
In Commercial Distribution

  • 00884838105645 ()
1149958

  • Carbon dioxide cuvette, reusable
Pediatric/Adult Airway Adapter
Respironics Novametrix, LLC
1149456
In Commercial Distribution

  • 00884838104822 ()
1149456

  • Carbon dioxide cuvette, reusable
Pediatric/Adult Airway Adapter
Respironics Novametrix, LLC
1149944
In Commercial Distribution

  • 00884838105638 ()
1149944

  • Carbon dioxide cuvette, reusable
Neonatal Airway Adapter
Respironics Novametrix, LLC
1149468
In Commercial Distribution

  • 00884838104839 ()
1149468

  • Carbon dioxide cuvette, reusable
Neonatal Airway Adapter
Respironics Novametrix, LLC
1149453
In Commercial Distribution

  • 00884838104815 ()
1149453

  • Carbon dioxide cuvette, reusable
NEONATAL AIRWAY ADAPTER
VYAIRE MEDICAL, INC.
16608
Not in Commercial Distribution

  • 10190752128668 ()
16608

  • Carbon dioxide cuvette, reusable
PEDIATRIC/ADULT AIRWAY ADAPTER
VYAIRE MEDICAL, INC.
16607
Not in Commercial Distribution

  • 10190752128651 ()
16607

  • Carbon dioxide cuvette, reusable
truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device
CUTERA, INC.
truSculpt 5 RF handpiece
In Commercial Distribution

  • 00816722022486 ()


  • Radio-frequency skin contouring system applicator, monopolar
truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device
CUTERA, INC.
truSculpt 2 RF handpiece
In Commercial Distribution

  • 00816722022479 ()


  • Radio-frequency skin contouring system applicator, monopolar
truSculpt iD Hands Free 40 Handpiece
CUTERA, INC.
truSculpt iD Hands Free 40
In Commercial Distribution

  • 00816722022462 ()


  • Radio-frequency skin contouring system applicator, monopolar
truSculpt 40 Hand Held RF Handpiece for iD
CUTERA, INC.
truSculpt 40 Hand Held
In Commercial Distribution

  • 00816722022455 ()


  • Radio-frequency skin contouring system applicator, monopolar
truSculpt 16 Hand Held RF Handpiece for iD
CUTERA, INC.
truSculpt 16 Hand Held
In Commercial Distribution

  • 00816722022448 ()


  • Radio-frequency skin contouring system applicator, monopolar
THERMAGE FLX HANDPIECE
SOLTA MEDICAL
TH-6
In Commercial Distribution

  • 00816995021278 ()
TH-6

  • Radio-frequency skin contouring system applicator, monopolar
No Description
CLASSYS Inc.
VLMHPB001
In Commercial Distribution

  • 08800016902969 ()


  • Radio-frequency skin contouring system applicator, monopolar
No Description
CLASSYS Inc.
VLMHPA001
In Commercial Distribution

  • 08800016902952 ()


  • Radio-frequency skin contouring system applicator, monopolar
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