AccessGUDID - DEVICE: BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) (00857335005039)

GUDID

Device Identifier (DI) Information

Brand Name: BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
Version or Model: 01M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Otsuka America Pharmaceutical Inc

Primary DI Number: 00857335005039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008314390 *Terms of Use

Device Description: This is the Metabolic Solutions Kit version of the kit.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52787	Helicobacter pylori urease IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZA	Test, Urea Adult And Pediatric (Breath),

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 144744b1-e8ca-476b-b141-2dbe4836e412
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 16, 2017