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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Direct Bilirubin Reagent 4X 20 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-911
In Commercial Distribution

  • 05060500090326 ()
IR750-911

  • Conjugated (direct) bilirubin IVD, reagent
Direct Bilirubin Reagent 3 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-WK
In Commercial Distribution

  • 05060500090319 ()
IR750-WK

  • Conjugated (direct) bilirubin IVD, reagent
Direct Bilirubin Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-X
In Commercial Distribution

  • 05060500090302 ()
IR750-X

  • Conjugated (direct) bilirubin IVD, reagent
Direct Bilirubin Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-R
In Commercial Distribution

  • 05060500090296 ()
IR750-R

  • Conjugated (direct) bilirubin IVD, reagent
AST Starter Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV082-L
In Commercial Distribution

  • 05060500090289 ()
UV082-L

  • Total aspartate aminotransferase (AST) IVD, reagent
AST Substrate Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV084-L
In Commercial Distribution

  • 05060500090272 ()
UV084-L

  • Total aspartate aminotransferase (AST) IVD, reagent
AST Reagent 4 X 50 mL + 1 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
UV085-911
In Commercial Distribution

  • 05060500090265 ()
UV085-911

  • Total aspartate aminotransferase (AST) IVD, reagent
AST Reagent 4 X 25 mL + 4 X 6.25 mL
INFRARED LABORATORY SYSTEMS LLC
UV085-WK
In Commercial Distribution

  • 05060500090258 ()
UV085-WK

  • Total aspartate aminotransferase (AST) IVD, reagent
AST Reagent 1 X 100 mL + 1 X 25 mL
INFRARED LABORATORY SYSTEMS LLC
UV085-X
In Commercial Distribution

  • 05060500090241 ()
UV085-X

  • Total aspartate aminotransferase (AST) IVD, reagent
AST Reagent 4 X 100 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
UV085-R
In Commercial Distribution

  • 05060500090234 ()
UV085-R

  • Total aspartate aminotransferase (AST) IVD, reagent
ALT Starter Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV182-L
In Commercial Distribution

  • 05060500090227 ()
UV182-L

  • Alanine aminotransferase (ALT) IVD, reagent
ALT Substrate Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV184-L
In Commercial Distribution

  • 05060500090210 ()
UV184-L

  • Alanine aminotransferase (ALT) IVD, reagent
ALT Reagent 4 X 50 mL + 1 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
UV185-911
In Commercial Distribution

  • 05060500090203 ()
UV185-911

  • Alanine aminotransferase (ALT) IVD, reagent
ALT Reagent 4 X 25 mL + 4 X 6.25 mL
INFRARED LABORATORY SYSTEMS LLC
UV185-WK
In Commercial Distribution

  • 05060500090197 ()
UV185-WK

  • Alanine aminotransferase (ALT) IVD, reagent
ALT Reagent 1 X 100 mL + 1 X 25 mL
INFRARED LABORATORY SYSTEMS LLC
UV185-X
In Commercial Distribution

  • 05060500090180 ()
UV185-X

  • Alanine aminotransferase (ALT) IVD, reagent
ALT Reagent 4 X 100 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
UV185-R
In Commercial Distribution

  • 05060500090173 ()
UV185-R

  • Alanine aminotransferase (ALT) IVD, reagent
Amylase Reagent 2 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
VI400-R
In Commercial Distribution

  • 05060500090166 ()
VI400-R

  • Total amylase IVD, reagent
Amylase Reagent 8 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
VI400-911
In Commercial Distribution

  • 05060500090159 ()
VI400-911

  • Total amylase IVD, reagent
Amylase Reagent 3 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
VI400-WK
In Commercial Distribution

  • 05060500090142 ()
VI400-WK

  • Total amylase IVD, reagent
Amylase Reagent 1 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
VI400-X
In Commercial Distribution

  • 05060500090135 ()
VI400-X

  • Total amylase IVD, reagent
Amylase Reagent 2 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
VI400-R
In Commercial Distribution

  • 05060500090128 ()
VI400-R

  • Total amylase IVD, reagent
AMP Alkaline Phosphatase Reagent 6 X 500 mL + 6 powder vials
INFRARED LABORATORY SYSTEMS LLC
VI121-L
In Commercial Distribution

  • 05060500090111 ()
VI121-L

  • Total alkaline phosphatase (ALP) IVD, reagent
AMP Alkaline Phosphatase Reagent 4 X 50 mL + 4 powder vials
INFRARED LABORATORY SYSTEMS LLC
VI120-911
In Commercial Distribution

  • 05060500090104 ()
VI120-911

  • Total alkaline phosphatase (ALP) IVD, reagent
AMP Alkaline Phosphatase Reagent 3 X 55mL + 3 powder wedges
INFRARED LABORATORY SYSTEMS LLC
VI120-WK
In Commercial Distribution

  • 05060500090098 ()
VI120-WK

  • Total alkaline phosphatase (ALP) IVD, reagent
AAMP Alkaline Phosphatase Reagent 1 X 250 mL + 1 powder vial
INFRARED LABORATORY SYSTEMS LLC
VI120-X
In Commercial Distribution

  • 05060500090081 ()
VI120-X

  • Total alkaline phosphatase (ALP) IVD, reagent
AMP Alkaline Phosphatase Reagent 3 X 250 mL + 3 powder vials
INFRARED LABORATORY SYSTEMS LLC
VI120-R
In Commercial Distribution

  • 05060500090074 ()
VI120-R

  • Total alkaline phosphatase (ALP) IVD, reagent
Albumin Reagent 6 x 1000mL
INFRARED LABORATORY SYSTEMS LLC
IR010-L
In Commercial Distribution

  • 05060500090067 ()
IR010-L

  • Albumin IVD, reagent
Albumin Reagent 8 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR010-911
In Commercial Distribution

  • 05060500090050 ()
IR010-911

  • Albumin IVD, reagent
Albumin Reagent 4 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
IR010-WK
In Commercial Distribution

  • 05060500090043 ()
IR010-WK

  • Albumin IVD, reagent
Albumin Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR010-X
In Commercial Distribution

  • 05060500090036 ()
IR010-X

  • Albumin IVD, reagent
Albumin Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR010-R
In Commercial Distribution

  • 05060500090029 ()
IR010-R

  • Albumin IVD, reagent
Automated Clinical Chemistry Analyzer IVD
INFRARED LABORATORY SYSTEMS LLC
IR-1200
In Commercial Distribution

  • 05060500090012 ()
IR-1200

  • Multiple clinical chemistry analyser IVD, laboratory
Automated Clinical Chemistry Analyzer IVD
INFRARED LABORATORY SYSTEMS LLC
IR-500
In Commercial Distribution

  • 05060500090005 ()
IR-500

  • Multiple clinical chemistry analyser IVD, laboratory
No Description
TOPCON CORPORATION
INFRARED COMMUNICATION UNIT
In Commercial Distribution

  • 04560126264640 ()


  • Phoropter, electric
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
OTSUKA ELECTRONICS CO.,LTD.
POCone
In Commercial Distribution

  • 04987035343417 ()


  • Infrared spectrometry breath analyser IVD
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
Not in Commercial Distribution

  • 04953170424724 ()


  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2307
In Commercial Distribution

  • 04953170396083 ()


  • Surgical microscope video camera filter switch
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
In Commercial Distribution

  • 04953170395994 ()


  • Software upgrade/unlocking key
Model 70500 Wabbo Infrared Lamp is made from a famous heat lamp manufacturer in China. Floor Type Style Lamp is contents a replaceable heads with manual controller it's a durable and safety lamp with 5 plastic legs base. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70500
In Commercial Distribution

  • 00816073022623 ()
70500

  • Musculoskeletal infrared phototherapy unit, non-wearable
Reflex TL, Skin Stapler with tissue lift, 35 regular
Conmed Corporation
3013R
In Commercial Distribution

  • 10653405050896 ()
  • 20653405050893 ()
  • 00653405050899 ()
3013R

  • Skin stapler/staple, non-bioabsorbable
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