Identity
- Trade Name
- Lateral protection FDA UDI
- Generic Name
- Bedrail FDA UDI
- Model / Reference
- 100415A0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046768038950 FDA UDI
- FDA Product Code
- BWN FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Category: Bedrail
Lateral protection by Maquet, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bedrail.
- Homecare Half Length Bed Rail Cross Bar Mount — Dynarex Corp. · Class I
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- MERITS — MERITS HEALTH PRODUCTS., INC. · Class I
- INVACARE® ASSIST BAR — Invacare Corp. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Composite Swing Rail — Dynarex Corp. · Class I
- Expansion Kit for D300 — Dynarex Corp. · 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 |
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Manufacturer
- Manufacturer
- Maquet, Inc.
Sources (1)
- FDA UDI a75d2c0a-e7ca-430f-816d-35a7a244aea5 32 fields · synced May 30, 2026