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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GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Industrial Source
1
In Commercial Distribution

  • 00860009591820 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - GAS, CALIBRATION (SPECIFIED CONCENTRATION) -
Middlesex Gases & Technologies, Inc.
1
In Commercial Distribution

  • 00860009591721 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixtures
Ilmo Products Company
1
In Commercial Distribution

  • 00860009591530 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Oxarc, Inc.
1
In Commercial Distribution

  • 00860009626232 ()


  • Carbon monoxide breath analyser
GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Test Mixture
Red Ball Oxygen Co., Inc.
1
In Commercial Distribution

  • 00860009625914 ()


  • Carbon monoxide breath analyser
Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
Norco, Inc.
Medical Calibration Gas
In Commercial Distribution

  • 00860009621909 ()


  • Carbon monoxide breath analyser
A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.
CAPNIA, INC.
C20112
In Commercial Distribution

  • 00858481006017 ()


  • Carbon monoxide breath analyser
No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00858086006818 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
3.0
In Commercial Distribution

  • 00858086006801 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
100025549-03
In Commercial Distribution

  • 10858086006624 ()
  • 00858086006627 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1107081-02
In Commercial Distribution

  • 10858086006617 ()
  • 00858086006610 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
100025549-02
In Commercial Distribution

  • 10858086006396 ()
  • 00858086006399 ()
100025549-02

  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1107081-01
In Commercial Distribution

  • 10858086006389 ()
  • 00858086006382 ()
1107081-01

  • Real-time position management respiratory gating system, optical
No Description
CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.
PFP-20300
In Commercial Distribution

  • 00863571000318 ()


  • Carbon monoxide breath analyser
No Description
CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.
FP-20021
Not in Commercial Distribution

  • 00863571000301 ()


  • Carbon monoxide breath analyser
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.3
In Commercial Distribution

  • 00856100006240 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 10856100006223 ()
  • 00856100006226 ()


  • Real-time position management respiratory gating system, optical
No Description
Varian Medical Systems Imaging Laboratory GmbH
2.0
In Commercial Distribution

  • 00856100006196 ()


  • Real-time position management respiratory gating system, optical
RGSC
Varian Medical Systems Imaging Laboratory GmbH
1.1
In Commercial Distribution

  • 00856100006028 ()


  • Real-time position management respiratory gating system, optical
Lung Diffusion Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Linde Gas & Equipment Inc.
1
In Commercial Distribution

  • 00850046301162 ()


  • Carbon monoxide breath analyser
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.2
In Commercial Distribution

  • 00899475002592 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.8
In Commercial Distribution

  • 00899475002479 ()


  • Real-time position management respiratory gating system, optical
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
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
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
Neonatal Airway Adapter
Respironics Novametrix, LLC
1149958
In Commercial Distribution

  • 00884838105645 ()
1149958

  • 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
Pediatric/Adult Airway Adapter
Respironics Novametrix, LLC
1149456
In Commercial Distribution

  • 00884838104822 ()
1149456

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

  • 00884838104815 ()
1149453

  • 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
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
MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA1800
Not in Commercial Distribution

  • 14250892901869 ()
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
In Commercial Distribution

  • 14250892904129 ()
36-PSA1800

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

  • 14250892904136 ()
36-PSA2000

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

  • 05099169297500 ()
  • 15099169297507 ()


  • Carbon monoxide breath analyser
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
CVS Health Digital Ovulation Test Kit 10 ct
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
1
In Commercial Distribution

  • 00050428083581 ()
322548

  • Natural conception assistance kit
20-Strip HCG Pregnancy Tests, 50-Strip LH-Ovulation Test, and 70 Plastic Urine Cups
WONDFO USA CO., LTD.
WS-H20L50-CA
In Commercial Distribution

  • 10816862024392 ()
  • 00816862024395 ()
  • 00816862024401 ()


  • Natural conception assistance kit
10-Strip HCG Pregnancy Tests,40-Strip LH-Ovulation Test, and 50 Plastic Urine Cups
WONDFO USA CO., LTD.
WS-H10L40
In Commercial Distribution

  • 10816862024378 ()
  • 00816862024371 ()
  • 00816862024388 ()


  • Natural conception assistance kit
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