Identity
- Trade Name
- Bariatric Homecare Bed Rails, 1 Pair FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- Half Length Bed Rail For use with the Bariatric Full Electric 42" Home Care Bed FDA UDI
- Model / Reference
- 10468 FDA UDI
- Description
- Half Length Bed Rail For use with the Bariatric Full Electric 42" Home Care Bed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784046815 FDA UDI
- FDA Product Code
- FNJ FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5120 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bedrail
Bariatric Homecare Bed Rails, 1 Pair by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bedrail.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Ritter — Midmark Corporation · Class I
- INVACARE® CARROLL ASSIST RAIL® — Invacare Corp. · Class II
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 |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 1f9f79bc-0d88-48cb-a457-f99e424fcf9b 33 fields · synced May 30, 2026