Identity
- Trade Name
- Air Float Static Air Seat Cushion FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- Air Float Static Air Seat Cushion (17"x17"x1.5") FDA UDI
- Model / Reference
- AF171715 FDA UDI
- Description
- Air Float Static Air Seat Cushion (17"x17"x1.5") FDA UDI
Identifiers
- Catalog Number
- AF171715 FDA UDI
- Primary DI / UDI-DI
- 00810006680164 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Freestanding patient positioner, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Air Float Static Air Seat Cushion by Primo Inc — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primo Inc
Sources (1)
- FDA UDI ae6b1283-3daf-443e-8faa-9f03d4de5360 35 fields · synced Jun 8, 2026