PyloPlus+ Urea Breath Test Lab Analyzer

FDA UDI

Class III (US FDA UDI)

by Arj Medical, Inc.

Identity

Trade Name: PyloPlus+ Urea Breath Test Lab Analyzer FDA UDI
Generic Name: Infrared spectrometry breath analyser IVD FDA UDI
Model / Reference: PPUBTLA-04 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860001810387 FDA UDI
PMA Number: P170022 FDA UDI
FDA Product Code: OZA FDA UDI
GMDN Term: Infrared spectrometry breath analyser IVD FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 866.3110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Infrared spectrometry breath analyser IVD

PyloPlus+ Urea Breath Test Lab Analyzer by Arj Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Infrared spectrometry breath analyser IVD.

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PyloPlus+ Urea Breath Test Pro Analyzer — Arj Medical, Inc. · Class III
PyloPlus+ Urea Breath Test Analyzer — Arj Medical, Inc. · Class III

Cleared under the same submission

P170022 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Arj Medical, Inc.

Sources (1)

FDA UDI 9c3a4234-77bf-4fc3-80b6-bdf438074a46 33 fields · synced May 29, 2026