Identity
- Trade Name
- CAIRE Diagnostics FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo Unit Instructions for Use, Fenom Pro, US Configuration - P/N IFU-3393, as required Instructions for Use, Fenom Pro, PN IFU-3264, as required AC Power Cord Cable, US - PN 415-0003, as required AC Power Cord Cable, UK - PN 415-0004, as required AC Power Cord Cable, Switzerland, PN415-0008, as required AC Power Cord Cable, Europlug, PN 415-0011, as required FDA UDI
- Model / Reference
- Fenom Pro, Demo FDA UDI
- Description
- Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo Unit Instructions for Use, Fenom Pro, US Configuration - P/N IFU-3393, as required Instructions for Use, Fenom Pro, PN IFU-3264, as required AC Power Cord Cable, US - PN 415-0003, as required AC Power Cord Cable, UK - PN 415-0004, as required AC Power Cord Cable, Switzerland, PN415-0008, as required AC Power Cord Cable, Europlug, PN 415-0011, as required FDA UDI
Identifiers
- Catalog Number
- 900-0009 FDA UDI
- Primary DI / UDI-DI
- 00860008017932 FDA UDI
- 510(k) Number
- K182874 FDA UDI
- FDA Product Code
- MXA FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3080 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic spirometer, professional
CAIRE Diagnostics by CAIRE Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182874 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 II | Pending data |
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Manufacturer
- Manufacturer
- CAIRE Diagnostics Inc.
Sources (1)
- FDA UDI 01ed92d2-fb76-47f8-96ea-086f0016cbae 35 fields · synced Jun 8, 2026