Identity
- Trade Name
- FloSense FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Pneumotachometer FDA UDI
- Model / Reference
- Klip FDA UDI
- Description
- Pneumotachometer FDA UDI
Identifiers
- Catalog Number
- 298010K FDA UDI
- Primary DI / UDI-DI
- B279298010K1 FDA UDI
- 510(k) Number
- K990962 FDA UDI
- FDA Product Code
- JAX FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2550 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
FloSense by Sdi Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sdi Diagnostics, Inc.
Sources (1)
- FDA UDI a49206ac-d43a-4b3e-adb2-95d20d802721 36 fields · synced Jun 6, 2026