AccessGUDID - DEVICE: Gastrolyzer (05060246860368)

GUDID

Device Identifier (DI) Information

Brand Name: Gastrolyzer
Version or Model: GastroCHECK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GASTROCHECK
Company Name: BEDFONT SCIENTIFIC LIMITED

Primary DI Number: 05060246860368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 293959094 *Terms of Use

Device Description: Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
36320	Ambient gas analyser	An electrically-powered device intended to measure the concentration of one or more gas(es) [e.g., oxygen (O2), carbon dioxide (CO2)] from the ambient environment (e.g., within a room), typically to monitor the work conditions of employees. It is typically a hand-held or wearable sensor unit with controls and display.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 8989ec85-77dd-4c14-a750-33b305b1c64e
Public Version Date: September 13, 2024
Public Version Number: 1
DI Record Publish Date: September 05, 2024