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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Total Bilirubin Reagent 1 X 250 mL + 1 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR450-X
In Commercial Distribution

  • 05060500090401 ()
IR450-X

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 3 X 250 mL + 3 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR450-R
In Commercial Distribution

  • 05060500090395 ()
IR450-R

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-L
In Commercial Distribution

  • 05060500090388 ()
IR700-L

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 8 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-911
In Commercial Distribution

  • 05060500090371 ()
IR700-911

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 4 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-WK
In Commercial Distribution

  • 05060500090364 ()
IR700-WK

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-X
In Commercial Distribution

  • 05060500090357 ()
IR700-X

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-R
In Commercial Distribution

  • 05060500090340 ()
IR700-R

  • Total bilirubin IVD, reagent
Direct Bilirubin Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-L
In Commercial Distribution

  • 05060500090333 ()
IR750-L

  • 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
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
The Infrared Lamp is one of the most inexpensive quality infrared lamp with light bulb in the U.S.
UPC MEDICAL SUPPLIES, INC.
L-100A/G-1R
In Commercial Distribution

  • 00831592004011 ()

  • Weight: 21 Pound
  • Height: 9 Inch
  • Width: 14 Inch
  • Length: 24 Inch


  • Musculoskeletal infrared phototherapy unit, non-wearable
BTM Light Weight Monitoring Defib Module
BOUND TREE MEDICAL, LLC
2525-61323
In Commercial Distribution

  • 00815277020664 ()


  • Blood pressure cuff, reusable
  • Transcutaneous blood gas monitor sensor
  • Intracardiac oximeter
  • General-purpose patient temperature probe, single-use
BTM Light Weight Monitoring Module / ECG, RESP, NPB, SPO2, P+T
BOUND TREE MEDICAL, LLC
2525-13623
In Commercial Distribution

  • 00815277020602 ()


  • Transcutaneous blood gas monitor sensor
  • Intracardiac oximeter
  • General-purpose patient temperature probe, single-use
  • Blood pressure cuff, reusable
Titan S IPL Handpiece
CUTERA, INC.
Titan S
In Commercial Distribution

  • 00816722022929 ()


  • Dermatological laser beam guiding handpiece
Titan V IPL Handpiece
CUTERA, INC.
Titan V
In Commercial Distribution

  • 00816722022905 ()


  • Dermatological laser beam guiding handpiece
Solera Titan IPL System
CUTERA, INC.
Solera Titan
In Commercial Distribution

  • 00816722021915 ()


  • Multi-modality skin surface treatment system
SWIT PATIENT LASER STOP
DJO, LLC
13651
In Commercial Distribution

  • 00888912236010 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
CVS Children's Pulse Oximeter
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
MD300C56
In Commercial Distribution

  • 00050428083574 ()


  • Pulse oximeter
The Therapy Light utilizes a perfect blend of deep red light. Additionally, the device includes fully digital controls with a built-in timer, allowing the ability to connect multiple panels together to create custom sizes, unique to your treatment needs.
E.SHINE LIGHTING CO., LIMITED
Kala Titan
Not in Commercial Distribution

  • 06977863220637 ()


  • Red/infrared light phototherapy unit
The Therapy Light utilizes a perfect blend of deep red light. Additionally, the device includes fully digital controls with a built-in timer, allowing the ability to connect multiple panels together to create custom sizes, unique to your treatment needs.
E.SHINE LIGHTING CO., LIMITED
Kala Duo Pro
Not in Commercial Distribution

  • 06977863220620 ()


  • Red/infrared light phototherapy unit
The Therapy Light utilizes a perfect blend of deep red light. Additionally, the device includes fully digital controls with a built-in timer, allowing the ability to connect multiple panels together to create custom sizes, unique to your treatment needs.
E.SHINE LIGHTING CO., LIMITED
Kala Apex
Not in Commercial Distribution

  • 06977863220613 ()


  • Red/infrared light phototherapy unit
The Therapy Light utilizes a perfect blend of deep red light. Additionally, the device includes fully digital controls with a built-in timer, allowing the ability to connect multiple panels together to create custom sizes, unique to your treatment needs.
E.SHINE LIGHTING CO., LIMITED
Kala Core
Not in Commercial Distribution

  • 06977863220606 ()


  • Red/infrared light phototherapy unit
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