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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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Vyaire - 14250892904136

MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA2000
In Commercial Distribution

  • 14250892904136 ()
36-PSA2000

  • Carbon monoxide breath analyser

Vyaire - 14250892904129

Mouthpiece Adaptor
Jaeger Medical GmbH
36-PSA1800
In Commercial Distribution

  • 14250892904129 ()
36-PSA1800

  • Carbon monoxide breath analyser

Micro Medical - 14250892901869

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

  • 14250892901869 ()
36-PSA1800

  • Carbon monoxide breath analyser

Micro Medical - 14250892901838

MOUTHPIECE ADAPTOR
Jaeger Medical GmbH
36-PSA2000
Not in Commercial Distribution

  • 14250892901838 ()
36-PSA2000

  • Carbon monoxide breath analyser

Micro Medical - 54250892980145

SmokeCheck
CAREFUSION U.K. 232 LIMITED
36-SC01-STK
Not in Commercial Distribution

  • 54250892980145 ()
36-SC01-STK

  • Carbon monoxide breath analyser

Micro Medical - 54250892980015

MicroCO
CAREFUSION U.K. 232 LIMITED
36-MC02-STK
Not in Commercial Distribution

  • 54250892980015 ()
36-MC02-STK

  • Carbon monoxide breath analyser

Vyaire - 54250892905506

MicroCO
Jaeger Medical GmbH
36-MC02-STK
In Commercial Distribution

  • 54250892905506 ()
36-MC02-STK

  • Carbon monoxide breath analyser

Micro Medical - 54250892901584

SmokeCheck
Jaeger Medical GmbH
36-SC01-STK
Not in Commercial Distribution

  • 54250892901584 ()
36-SC01-STK

  • Carbon monoxide breath analyser

Micro Medical - 54250892901362

MicroCO
Jaeger Medical GmbH
36-MC02-STK
Not in Commercial Distribution

  • 54250892901362 ()
36-MC02-STK

  • Carbon monoxide breath analyser

OsteoMed - 00845694002325

90 x 90 x .6mm Mini, Formable Mesh Plate
OSTEOMED LLC
210-2001
In Commercial Distribution

  • 00845694002325 ()

  • Length: 88 Millimeter
210-2001

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

MediPure Lung Diffusion Mixture - 00850046301162

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

Lung Diffusion Mixture - 00860009629509

GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Matheson Tri-Gas, Inc.
1
In Commercial Distribution

  • 00860009629509 ()


  • Carbon monoxide breath analyser

Lung Diffusion Mixture - 00860009626232

GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
Oxarc, Inc.
1
In Commercial Distribution

  • 00860009626232 ()


  • Carbon monoxide breath analyser

Lung Diffusion Test Mixture - 00860009625914

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

  • 00860009625914 ()


  • Carbon monoxide breath analyser

NorLab - 00860009621909

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

Lung Diffusion Mixture - 00860009617407

GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture
A-Ox Welding Supply, Co., Inc.
1
In Commercial Distribution

  • 00860009617407 ()


  • Carbon monoxide breath analyser

Lung Diffusion Gas Mixture - 00860009597815

GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Gas Mixture
General Air Service & Supply Co
1
In Commercial Distribution

  • 00860009597815 ()


  • Carbon monoxide breath analyser

Lung Diffusion Mixture - 00860009591820

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

  • 00860009591820 ()


  • Carbon monoxide breath analyser

Lung Diffusion - 00860009591721

GAS, CALIBRATION (SPECIFIED CONCENTRATION) - GAS, CALIBRATION (SPECIFIED CONCENTRATION) -
Middlesex Gases & Technologies, Inc.
1
In Commercial Distribution

  • 00860009591721 ()


  • Carbon monoxide breath analyser

Lung Diffusion Mixtures - 00860009591530

GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixtures
Ilmo Products Company
1
In Commercial Distribution

  • 00860009591530 ()


  • Carbon monoxide breath analyser

Lung Diffusion Mixture - 00860009502000

Used for calibrating analyzers that measure the amount of carbon monoxide diffused through the lungs.
Roberts Oxygen Company, Inc.
1
In Commercial Distribution

  • 00860009502000 ()


  • Carbon monoxide breath analyser

CoSense ETCO Monitor - 00858481006017

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

Pivot Breath Sensor - 00863571000318

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

Carbon Monoxide Breath Sensor - 00863571000301

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

TABATABA V2 - 03760253450294

No Description
FIM MEDICAL
V2
In Commercial Distribution

  • 03760253450294 ()


  • Carbon monoxide breath analyser

Scott Medical Products - 00819601020429

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

Scott Medical Products - 00819601020412

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

Scott Medical Products - 00819601020405

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

Scott Medical Products - 00819601020399

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

Airgas Healthcare - 00819601020047

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

iCO Quit Smokerlyzer - 05060246860429

The iCOquit breath carbon monoxide (CO) monitor is intended for single person use by individuals wanting to measure the amount of CO on their breath in the home environment, as a motivational aid to help them in their attempt to stop smoking. The iCOquit can also be used by healthcare professionals with individuals in smoking cessation programmes and research.
BEDFONT SCIENTIFIC LIMITED
iCO Quit
In Commercial Distribution

  • 05060246860429 ()
ICOQUIT

  • Carbon monoxide breath analyser

Smokerlyzer - 05060246860047

The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment.
BEDFONT SCIENTIFIC LIMITED
Micro+
In Commercial Distribution

  • 05060246860047 ()
MICROADV

  • Carbon monoxide breath analyser

ToxCO - 05060246860030

The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients.
BEDFONT SCIENTIFIC LIMITED
ToxCO
In Commercial Distribution

  • 05060246860030 ()
TOXCO-USA

  • Carbon monoxide breath analyser

BreathCO - 15099169297507

BREATHCO MONITOR
VITALOGRAPH (IRELAND) LIMITED
2900
In Commercial Distribution

  • 05099169297500 ()
  • 15099169297507 ()


  • Carbon monoxide breath analyser

Darby Dental Supply, LLC - 00889813032336

POLY CROWNS REFILL Number 27
DARBY DENTAL SUPPLY, LLC
9518542
In Commercial Distribution

  • 00889813032329 ()
  • 00889813032336 ()
9518542

  • Preformed dental crown, temporary

Tinto ZFAND3 (BSB-169) - B502BSB379770

Tinto ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-7
In Commercial Distribution

  • B502BSB379770 ()

  • Total Volume: 7 Milliliter
BSB-3797-7

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

Tinto ZFAND3 (BSB-169) - B502BSB379730

Tinto ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-3
In Commercial Distribution

  • B502BSB379730 ()

  • Total Volume: 3 Milliliter
BSB-3797-3

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

ZFAND3 (BSB-169) - B502BSB379710

ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-1
In Commercial Distribution

  • B502BSB379710 ()

  • Total Volume: 1 Milliliter
BSB-3797-1

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

ZFAND3 (BSB-169) - B502BSB3797050

ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-05
In Commercial Distribution

  • B502BSB3797050 ()

  • Total Volume: 0.5 Milliliter
BSB-3797-05

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

ZFAND3 (BSB-169) - B502BSB3797010

ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-01
In Commercial Distribution

  • B502BSB3797010 ()

  • Total Volume: 0.1 Milliliter
BSB-3797-01

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

Tinto ZFAND3 (BSB-169) - B502BSB3797150

Tinto ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-15
In Commercial Distribution

  • B502BSB3797150 ()

  • Total Volume: 15 Milliliter
BSB-3797-15

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

ID CORE CONTROL - 08437013457040

The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control

TIDI - 00618125183685

RECTANGLE, .88" x 3" x 5", 1 Each
TIDI PRODUCTS, LLC
33274
In Commercial Distribution

  • 00618125183685 ()


  • Multifunction body cushion

EVONOS GMBH & Co - 00821925012424

GUILFORD ADHESION PICK 45 DEGREE TIP ANGLE 1 MM TIP ANGLE STAINLESS STEEL
Gyrus ACMI, LLC
130260
In Commercial Distribution

  • 00821925012424 ()


  • Middle ear pick

JUNIORTHO PLATING SYSTEM - 18053800899755

JPS SS LOCKING SCREW L16MM DOUBLE START THREAD D3.0MM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800899755 ()

  • Width: 88 Millimeter
5413016

  • Orthopaedic bone screw, non-bioabsorbable, sterile

FREE GLIDING SCFE SCREW SYSTEM - 07540194002549

Female Component 88/90mm Ø7.3mm
Orthopediatrics Canada ULC
SCF-F73-88S/90L
In Commercial Distribution

  • 07540194002549 ()

  • Length: 88 Millimeter
  • Outer Diameter: 7.3 Millimeter
  • Length: 90 Millimeter
SCF-F73-88S/90L

  • Orthopaedic bone screw (non-sliding)

FREE GLIDING SCFE SCREW SYSTEM - 07540194002365

Female Component 88/90mm Ø6.5mm
Orthopediatrics Canada ULC
SCF-F65-88S/90L
In Commercial Distribution

  • 07540194002365 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 88 Millimeter
  • Length: 90 Millimeter
SCF-F65-88S/90L

  • Orthopaedic bone screw (non-sliding)

Hemo-QC - 00858352006009

Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution

  • 00858352006009 ()
H9200

  • Multiple blood group genotyping IVD, control

ID CORE XT - 08437013457019

ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)

Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides - 10888234100065

No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution

  • 10888234100065 ()
800-20202-08

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
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