AccessGUDID - DEVICE: PyloPlus+ Urea Breath Test Kit (00860001810325)

GUDID

Device Identifier (DI) Information

Brand Name: PyloPlus+ Urea Breath Test Kit
Version or Model: PPUBTK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Arj Medical, Inc.

Primary DI Number: 00860001810325
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
61476	Carbon isotope breath test kit IVD	A collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon isotope-labelled substrate and breath specimen containers or collection card. The test relies on the metabolism of the substrate and expiration of carbon isotopes in CO2. It can be administered by a healthcare professional in a clinical setting or alternatively by the patient at home, for subsequent analysis in a clinical laboratory or at the point-of-care. This is a single-use device.	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: 84eb304d-31c8-4185-8341-553c6880c0ad
Public Version Date: January 28, 2025
Public Version Number: 1
DI Record Publish Date: January 20, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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