Identity
- Trade Name
- AlveoVac Exraction System-USA 24VDC FDA UDI
- Generic Name
- Laboratory instrument/analyser pump IVD FDA UDI
- Device Name
- A stand-alone accessory which extracts breath samples from approved QuinTron breath collection devices and injects the sample into the BreathTracker SC or H2+ breath analyzer. Approved QuinTron collection devices include our following products: 10ml AlveoVac glass vials, sample holding bags, and QuinTron syringes. FDA UDI
- Model / Reference
- QT05200-M FDA UDI
- Description
- A stand-alone accessory which extracts breath samples from approved QuinTron breath collection devices and injects the sample into the BreathTracker SC or H2+ breath analyzer. Approved QuinTron collection devices include our following products: 10ml AlveoVac glass vials, sample holding bags, and QuinTron syringes. FDA UDI
Identifiers
- Catalog Number
- QT05200-M FDA UDI
- Primary DI / UDI-DI
- 00850010197500 FDA UDI
- FDA Product Code
- NRH FDA UDI
- GMDN Term
- Laboratory instrument/analyser pump IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1820 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laboratory instrument/analyser pump IVD
AlveoVac Exraction System-USA 24VDC by Quintron Instrument Co. Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory instrument/analyser pump IVD.
- LOANER ALVEOVAC EXTRACTOR — QUINTRON INSTRUMENT CO. INC. · Class I
- EXTRACTOR REPAIR — QUINTRON INSTRUMENT CO. INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quintron Instrument Co. Inc.
Sources (1)
- FDA UDI c082b329-6a70-4d5c-bb39-5828bf65c9fa 34 fields · synced Jun 8, 2026