Identity
- Trade Name
- Side-rail spacer FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- Electrical Hospital Bed Accessory to fill the gap between the foot board and side-rail FDA UDI
- Model / Reference
- PC-5112 FDA UDI
- Description
- Electrical Hospital Bed Accessory to fill the gap between the foot board and side-rail FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04527799701568 FDA UDI
- FDA Product Code
- FNL FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5100 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
Side-rail spacer by Paramount Bed Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bedrail.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Paramount Bed Co., Ltd.
Sources (1)
- FDA UDI aa3d7112-44e2-4629-a750-b17007217c15 33 fields · synced Jun 6, 2026