Identity
- Trade Name
- Vac-Pac EUDAMEDOlympic Vac-Pac FDA UDI
- Generic Name
- Patient positioning vacuum mattress FDA UDI
- Device Name
- Olympic Vac-Pac and Vac-Pac Covers EUDAMEDOlympic Vac-Pac Size 35 FDA UDI
- Model / Reference
- 51635 EUDAMEDSize 35 FDA UDI
- Description
- Olympic Vac-Pac Size 35 FDA UDI
Identifiers
- Catalog Number
- 51635 FDA UDI
- Primary DI / UDI-DI
- 00382830005425 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00021DT EUDAMED
- Direct Marketing DI
- 00382830005425 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioning vacuum mattress FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vac-Pac by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 038283NA00021DT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 3bf141dd-5d33-4a05-a24b-1ae6e423341b 61 fields · synced Jul 15, 2026
- FDA UDI 46dcac04-3b8b-40bb-b694-2899e9240ef8 35 fields · synced May 30, 2026