AccessGUDID - DEVICE: BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) (00857335005008)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00857335005008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008314390 *Terms of Use

Device Description: The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.

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 [?]
P100025	000

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: 786bc018-36ec-4044-9cd0-e6b8d3d8f562
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 16, 2017