AccessGUDID - DEVICE: PyloPlus+ Urea Breath Test Pro Analyzer (00860001810370)

GUDID

Device Identifier (DI) Information

Brand Name: PyloPlus+ Urea Breath Test Pro Analyzer
Version or Model: PPUBTA-16
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Arj Medical, Inc.

Primary DI Number: 00860001810370
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006808397 *Terms of Use

Device Description: No description.

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:	Yes
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?
17474	Infrared spectrometry breath analyser IVD	An electrically-powered laboratory or point-of-care instrument designed to use infrared spectrometry technology for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is typically used to measure analytes such as ingested carbon isotopes that have been metabolized (e.g., 13C, 14C) to establish a correlation with metabolic profiles or disorders [e.g., gastrointestinal H. pylori infection]. The device operates with minimal technician involvement and complete automation of all procedural steps.	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 [?]
P170022	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: 0e7f2563-2d4b-495e-855d-c041cd886878
Public Version Date: January 28, 2025
Public Version Number: 1
DI Record Publish Date: January 20, 2025