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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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Anesthesia Circuit Kit - 10889483612026

60" Pediatric Anes. Circuit, Par-Wye, GSE W/Port
WESTMED, INC.
R-6844
In Commercial Distribution

  • 20889483612023 ()
  • 10889483612026 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483612019

60" Adult Anes. Circuit; Par-Wye, GSE, 2L Latex Free
WESTMED, INC.
R-6619
In Commercial Distribution

  • 20889483612016 ()
  • 10889483612019 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483612002

60" Adult Anesthesia Circuit; Swivel Wye, 2L LF Bag
WESTMED, INC.
R-6015
In Commercial Distribution

  • 20889483612009 ()
  • 10889483612002 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609064

PEDS CIRCUIT, 60IN COAXIAL TBG
WESTMED, INC.
9812
In Commercial Distribution

  • 30889483609068 ()
  • 10889483609064 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609057

120" Uni-lim™ coaxial circuit, patient elbow, in-line HMEF with sampling port, clip, 3L latex-free breathing bag, disposable
WESTMED, INC.
9811
In Commercial Distribution

  • 30889483609051 ()
  • 10889483609057 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609040

72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable
WESTMED, INC.
9810
In Commercial Distribution

  • 30889483609044 ()
  • 10889483609040 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609033

72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port,medium adult mask, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable
WESTMED, INC.
9809
In Commercial Distribution

  • 30889483609037 ()
  • 10889483609033 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609026

72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, in-line mini HMEF with sample port, patient and machine cuffs, M/M GSL 10' X .050ID X .108OD, 3M Red Dot ECG lead 5 pack, 3L latex-free breathing bag, disposable
WESTMED, INC.
9808
In Commercial Distribution

  • 30889483609020 ()
  • 10889483609026 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609019

Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable
WESTMED, INC.
9807
In Commercial Distribution

  • 30889483609013 ()
  • 10889483609019 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483609002

120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, disposable
WESTMED, INC.
9806
In Commercial Distribution

  • 30889483609006 ()
  • 10889483609002 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483608999

72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 2L latex-free breathing bag, disposable
WESTMED, INC.
9805
In Commercial Distribution

  • 30889483608993 ()
  • 10889483608999 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483608982

60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable
WESTMED, INC.
9804
In Commercial Distribution

  • 30889483608986 ()
  • 10889483608982 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483608975

60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable, med mask
WESTMED, INC.
9803
In Commercial Distribution

  • 30889483608979 ()
  • 10889483608975 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483608968

120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L latex-free breathing bag, disposable
WESTMED, INC.
9802
In Commercial Distribution

  • 30889483608962 ()
  • 10889483608968 ()


  • Anaesthesia breathing circuit, single-use

Anesthesia Circuit Kit - 10889483608951

96" flexible dual limb | patient elbow with sampling port parallel wye | in-line mini HMEF with sample port large adult mask | M/M GSL 10' X .050ID X .108OD 3L latex-fee breathing bag | all disposable
WESTMED, INC.
9801
In Commercial Distribution

  • 30889483608955 ()
  • 10889483608951 ()


  • Anaesthesia breathing circuit, single-use

Vital Signs™ - 10889483597699

Pediatric Anesthesia Breathing Circuit
AIRLIFE
B835XXX4
In Commercial Distribution

  • 30889483597693 ()
  • 10889483597699 ()
  • 10190752152908 ()
B835XXX4

  • Anaesthesia breathing circuit, single-use

Vital Signs™ - 10889483597484

Vital Signs™ Pediatric Anesthesia Breathing Circuit
AIRLIFE
B17A5X54
In Commercial Distribution

  • 30889483597488 ()
  • 10889483597484 ()
  • 10190752124172 ()
B17A5X54

  • Anaesthesia breathing circuit, single-use

Vital Signs™ - 10889483597422

Vital Signs™ Pediatric Anesthesia Breathing Circuit
AIRLIFE
B1754XX4
In Commercial Distribution

  • 30889483597426 ()
  • 10889483597422 ()

  • Length: 108 Inch
B1754XX4

  • Anaesthesia breathing circuit, single-use

AirLife™ - 10889483595886

AirLife™ Adult Heated Wire Circuit Kit Single-limb, Single-heated circuit Contains AH102 Circuit, AH290 Chamber
AIRLIFE
AH202
In Commercial Distribution

  • 30889483595880 ()
  • 10889483595886 ()
  • 10190752145153 ()
AH202

  • Inspiratory line humidification chamber, single-use

AirLife™ - 10889483595855

AirLife™ Infant Single Limb Heated Wire Circuit Kit Single-limb, Single-heated, continuous-flow circuit (>4 L/min) Contains AH032 Circuit, AH290 Chamber
AIRLIFE
AH132
In Commercial Distribution

  • 30889483595859 ()
  • 10889483595855 ()
  • 10190752145122 ()
AH132

  • Inspiratory line humidification chamber, single-use

Vital Signs™ - 10889483595596

Limb-O™ Single Limb Anesthesia Breathing Circuit
AIRLIFE
AFTXXXX4PX6
In Commercial Distribution

  • 30889483595590 ()
  • 10889483595596 ()
  • 10190752152243 ()
AFTXXXX4PX6

  • Anaesthesia breathing circuit, single-use

AirLife™ - 10889483580035

AirLife™ Pediatric Mouth-to-Mask Resuscitator Oxygen Port, Filter, 6 inch (15 cm) Tubing, Mouthpiece
AIRLIFE
2K8013
In Commercial Distribution

  • 30889483580039 ()
  • 10889483580035 ()
2K8013

  • Pulmonary resuscitator, manual, single-use

AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) - 10889483571064

AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) Crush Resistant Oxygen Tubing with Adult Aerosol Mask
AIRLIFE
002433
In Commercial Distribution

  • 30889483571068 ()
  • 10889483571064 ()
  • 10190752114821 ()
002433

  • Benchtop nebulizer, non-heated

Disposable Anesthesia Breathing Circuit - 10889483562789

Breathing Circuit, Pediatric, 60", Parallel Wye w/Port
WESTMED, INC.
5705-S
In Commercial Distribution

  • 20889483562786 ()
  • 10889483562789 ()


  • Anaesthesia breathing circuit, single-use

Avalon Biomed NeoSEALER Flo 40 Flo Tips (Int'l) - 00850008515286

Avalon Biomed NeoSEALER Flo 40 Flo Tips (Int'l)
NUSMILE, LTD.
CKT40
Not in Commercial Distribution

  • 00850008515286 ()


  • Dental material injection cannula, single-use

Avalon Biomed NeoSEALER Flo 40 Flex Flo Tips (Int'l) - 00850008515279

Avalon Biomed NeoSEALER Flo 40 Flex Flo Tips (Int'l)
NUSMILE, LTD.
FFT40
In Commercial Distribution

  • 00850008515279 ()


  • Dental material injection cannula, single-use

Avalon Biomed NeoSEALER Flo 10 Flex Flo Tips (Int'l) - 00850008515262

Avalon Biomed NeoSEALER Flo 10 Flex Flo Tips (Int'l)
NUSMILE, LTD.
FFT10
Not in Commercial Distribution

  • 00850008515262 ()


  • Dental material injection cannula, single-use

Avalon Biomed NeoSEALER Flo Starter Kit 2.2 g (Int'l) - 00850008515125

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
NUSMILE, LTD.
ANSIK
In Commercial Distribution

  • 00850008515125 ()

  • Weight: 2.2 Gram


  • Hygroscopic dental cement

AdaptDx Pro Eye Cups - 00850006785049

Left and right eye cups for the AdaptDx Pro headset.
MACULOGIX, INC.
10319
In Commercial Distribution

  • 10850006785046 ()
  • 00850006785049 ()


  • Adaptometer

Alere NT-proBNP for Alinity Reagent Kit (200 Tests) - 05055845400596

The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system. In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
AXIS-SHIELD DIAGNOSTICS LIMITED
04S7921
In Commercial Distribution

  • 05055845400596 ()
04S7921

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA - 05055845400497

The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments
AXIS-SHIELD DIAGNOSTICS LIMITED
FCCP600
In Commercial Distribution

  • 05055845400497 ()
FCCP600

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA - 05055845400008

The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
AXIS-SHIELD DIAGNOSTICS LIMITED
FCCP600
Not in Commercial Distribution

  • 05055845400008 ()
FCCP600

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

AirSculpt Air Hose (IN) - 00850000712461

No Description
Millennium Medical Technologies, Inc.
TD-10010
In Commercial Distribution

  • 00850000712461 ()


  • Liposuction system

Adult Single Heated Wire Breathing Circuit 1.6M (63")(Kit 1) - 05055788708698

No Description
FLEXICARE MEDICAL LIMITED
038-31-101U
In Commercial Distribution

  • 05055788708698 ()


  • Ventilator breathing circuit, single-use

Adult Single Heated Wire Breathing System 1.6M (63") (Kit 2) - 05055788708681

No Description
FLEXICARE MEDICAL LIMITED
038-31-102U
In Commercial Distribution

  • 05055788708681 ()


  • Ventilator breathing circuit, single-use

Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 1) - 05055788708674

No Description
FLEXICARE MEDICAL LIMITED
038-31-201U
In Commercial Distribution

  • 05055788708674 ()


  • Ventilator breathing circuit, single-use

Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 2) - 05055788708667

No Description
FLEXICARE MEDICAL LIMITED
038-31-202U
In Commercial Distribution

  • 05055788708667 ()


  • Ventilator breathing circuit, single-use

Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 3) - 05055788708650

No Description
FLEXICARE MEDICAL LIMITED
038-31-203U
In Commercial Distribution

  • 05055788708650 ()


  • Ventilator breathing circuit, single-use

Adult Convertible Heated Wire B/S 1.6M (63") (Kit 1) - 05055788708643

No Description
FLEXICARE MEDICAL LIMITED
038-31-301U
In Commercial Distribution

  • 05055788708643 ()


  • Ventilator breathing circuit, single-use

Adult Single Limb Heated Wire B/S 1.6M (63") (Kit 1) - 05055788708636

No Description
FLEXICARE MEDICAL LIMITED
038-31-401U
In Commercial Distribution

  • 05055788708636 ()


  • Ventilator breathing circuit, single-use

Adult Single Limb Heated Wire Breathing Circuit (63")(Kit 2) - 05055788708629

No Description
FLEXICARE MEDICAL LIMITED
038-31-402U
In Commercial Distribution

  • 05055788708629 ()


  • Ventilator breathing circuit, single-use

Adult Single Limb Heated Wire B/C Kit 1.6M (63")(Kit 3) - 05055788708612

No Description
FLEXICARE MEDICAL LIMITED
038-31-403U
In Commercial Distribution

  • 05055788708612 ()


  • Ventilator breathing circuit, single-use

Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1) - 05055788708605

No Description
FLEXICARE MEDICAL LIMITED
038-31-501U
In Commercial Distribution

  • 05055788708605 ()


  • Ventilator breathing circuit, single-use

Adult Smoothbore Single Limb H/W B/c Kit 1.6M (63") (Kit 1) - 05055788708599

No Description
FLEXICARE MEDICAL LIMITED
038-31-601U
In Commercial Distribution

  • 05055788708599 ()


  • Ventilator breathing circuit, single-use

FUJIFILM - 04547410389005

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard

FUJIFILM - 04547410388992

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard

ImmunoWELL Cardiolipin (IgM) Test - 00613745031002

The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.
Genbio
800-3100
In Commercial Distribution

  • 00613745031002 ()

  • 96 tests
3100

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoWELL Cardiolipin (IgG) Test - 00613745030906

The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.
Genbio
800-3090
In Commercial Distribution

  • 00613745030906 ()

  • 96 tests
3090

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

AirLife™ - 10190752156289

ABG Accessories
VYAIRE MEDICAL, INC.
70072950
In Commercial Distribution

  • 50190752156287 ()
  • 10190752156289 ()
70072950

  • Arterial blood sampling kit

AirLife™ - 10190752155893

Arterial Blood Sampler
VYAIRE MEDICAL, INC.
9722SL
In Commercial Distribution

  • 50190752155891 ()
  • 10190752155893 ()
9722SL

  • Arterial blood sampling kit
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