Identity
- Trade Name
- ArroAir Max & Deluxe FDA UDI
- Generic Name
- Flotation therapy bed, adult FDA UDI
- Device Name
- ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells secondary support FDA UDI
- Model / Reference
- P-108060 FDA UDI
- Description
- ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells secondary support FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869937000053 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Flotation therapy bed, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
No
FDA UDI
Category: Flotation therapy bed, adult
ArroAir Max & Deluxe by Arrowhead Healthcare Supply, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Arrowhead Healthcare Supply, Llc
Sources (1)
- FDA UDI 344523ed-228b-44b5-9e99-62592ce05cfc 33 fields · synced May 31, 2026