Identity
- Trade Name
- IV pole FDA UDI
- Generic Name
- Freestanding/bed-attached intravenous pole FDA UDI
- Device Name
- Electrical Hospital Bed Accessory to be used for holding other medical devices such as infusion bag. FDA UDI
- Model / Reference
- KC-56U FDA UDI
- Description
- Electrical Hospital Bed Accessory to be used for holding other medical devices such as infusion bag. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04527799700349 FDA UDI
- FDA Product Code
- FNL FDA UDI
- GMDN Term
- Freestanding/bed-attached intravenous pole 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: Freestanding/bed-attached intravenous pole
IV pole by Paramount Bed Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding/bed-attached intravenous pole.
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- Enercon — PRYOR PRODUCTS · Class I
- BV Medical — Medical, Inc. · Class I
- B-Braun — PRYOR PRODUCTS · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paramount Bed Co., Ltd.
Sources (2)
- FDA UDI d0964875-4b7c-4980-b35d-bd797b181aa8 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026