Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- VI-DoC_Reusable Patient restraint EUDAMEDS18061PP: Patient Safety Strap, EU GE Part Number: 5405557 007 FDA UDI
- Model / Reference
- GE5405557 EUDAMED112007 FDA UDI
- Description
- S18061PP: Patient Safety Strap, EU GE Part Number: 5405557 007 FDA UDI
Identifiers
- Catalog Number
- GE5405557 FDA UDI
- Primary DI / UDI-DI
- 00615521015558 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN11200785 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Limb/torso/head restraint, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Device sterilization/disinfection container, reusable
Allen by Hill-Rom, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0615521GMN11200785 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (2)
- EUDAMED bdfbf4a1-0cac-4628-817f-03ee7bb01268 61 fields · synced Jul 17, 2026
- FDA UDI 3331b842-ed5b-4351-a7da-7ef58afb5d6c 35 fields · synced May 30, 2026