PyloPlus+ Urea Breath Test Analyzer

Basic Information

• Brand Name: PyloPlus+ Urea Breath Test Analyzer
• Primary DI: 00860001810363
• Version / Model: PPUBTA-02
• Company Name: Arj Medical, Inc.
• Labeler DUNS: 006808397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-20
• Public Version: 1
• Public Version Date: 2025-01-28
• Public Version Status: New
• Public Device Record Key: 85fa93e5-2474-4f71-ab8c-8f1a3998d4f2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OZA	Test, Urea Adult And Pediatric (Breath),	Microbiology	866.3110	3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001810363	GS1

Premarket Submissions

Submission Number	Supplement Number
P170022	000