Identity
- Trade Name
- Devon FDA UDI
- Generic Name
- Foam-filled bed mattress overlay FDA UDI
- Device Name
- Adult Head Positioner,Blue FDA UDI
- Model / Reference
- 580022 FDA UDI
- Description
- Adult Head Positioner,Blue FDA UDI
Identifiers
- Catalog Number
- 580022 FDA UDI
- Primary DI / UDI-DI
- 10884527003914 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Foam-filled bed mattress overlay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Commercial Distribution
- 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
Yes
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
Category: Foam-filled bed mattress overlay
Devon by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foam-filled bed mattress overlay.
- AtmosAir 9000X — Arjohuntleigh, Inc. · Class I
- Therarest — Arjohuntleigh, Inc. · Class I
- AtmosAir 9000X — Arjohuntleigh, Inc. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- AtmosAir 9000X — Arjohuntleigh, Inc. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Therarest — Arjohuntleigh, Inc. · Class I
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
- Cardinalhealth
Sources (1)
- FDA UDI 368fae5b-65e8-4962-aa03-58c6a47e10b1 36 fields · synced May 30, 2026