Identity
- Trade Name
- Home Bed Assist Rail, Adjustable FDA UDI
- Generic Name
- Bedrail FDA UDI
- Model / Reference
- 10461 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784046112 FDA UDI
- FDA Product Code
- ILS FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
Home Bed Assist Rail, Adjustable by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bedrail.
- ProBasics — COMPASS HEALTH BRANDS CORP. · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class I
- INVACARE® ASSIST BAR — Invacare Corp. · Class II
- 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 f9442582-079e-4baa-b957-ae9213e98ba2 32 fields · synced Jun 8, 2026