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Zephyr Patient Positioning and Transfer System
EUDAMEDFDA UDIClass I (EU MDR)
Ref ZBL-1-100
by Diacor Inc.
Identity
- Trade Name
- Zephyr Patient Positioning and Transfer System EUDAMEDFDA UDI
- Generic Name
- Patient lifting system stretcher FDA UDI
- Device Name
- Zephyr Air Blowers & Accessories EUDAMEDZephyr Blower Kit for 110-120v FDA UDI
- Model / Reference
- ZBL-1-100 EUDAMEDFDA UDI
- Description
- Zephyr Blower Kit for 110-120v FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZBL11000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B237BLOWERWP EUDAMED
- Direct Marketing DI
- B237ZBL11000 EUDAMED
- 510(k) Number
- K121929 FDA UDI
- FDA Product Code
- FRZ FDA UDI
- EMDN Code
- V08050399 PATIENT TRANSFER LIFTS - OTHER EUDAMED
- GMDN Term
- Patient lifting system stretcher FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6775 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Zephyr Patient Positioning and Transfer System by Diacor Inc. — 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 | ++B237BLOWERWP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diacor Inc.
- EUDAMED SRN
- US-MF-000017181
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 37462e81-292e-42af-8fc3-567da1507476 61 fields · synced May 30, 2026
- FDA UDI 2ab67a7d-f2de-4148-aced-5dbb175baa83 34 fields · synced May 30, 2026