Identity
- Trade Name
- PyloPlus+ Urea Breath Test Pro Analyzer FDA UDI
- Generic Name
- Infrared spectrometry breath analyser IVD FDA UDI
- Model / Reference
- PPUBTA-16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001810370 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared spectrometry breath analyser IVD
PyloPlus+ Urea Breath Test Pro 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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- BreathID Smart System — MERIDIAN BIOSCIENCE ISRAEL LTD · Class I
- POC-AS10 Auto sampler — Otsuka Electronics · Class I
- POCone Infrared Spectrophotometer — Otsuka Electronics · Class I
- PyloPlus+ Urea Breath Test Analyzer — Arj Medical, Inc. · Class III
- PyloPlus+ Urea Breath Test Lab Analyzer — Arj Medical, Inc. · Class III
Cleared under the same submission
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 0e7f2563-2d4b-495e-855d-c041cd886878 33 fields · synced Jun 1, 2026