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 for US Instructions for Use, Fenom Pro, US Configuration - P/N IFU-3393 AC Power Cord Cable, US - PN 415-0003 FDA UDI
- Model / Reference
- Fenom Pro, US FDA UDI
- Description
- Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for US Instructions for Use, Fenom Pro, US Configuration - P/N IFU-3393 AC Power Cord Cable, US - PN 415-0003 FDA UDI
Identifiers
- Catalog Number
- 900-0005 FDA UDI
- Primary DI / UDI-DI
- 00860008017918 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 d650c8f8-13b4-490f-872e-8a32767b68b9 36 fields · synced May 30, 2026