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Zephyr Patient Positioning and Transfer System
FDA UDIClass II (US FDA UDI)
by Diacor Inc.
Identity
- Trade Name
- Zephyr Patient Positioning and Transfer System FDA UDI
- Generic Name
- Patient lifting system stretcher FDA UDI
- Device Name
- Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 2 screw mount design FDA UDI
- Model / Reference
- ZEP-AUB-52 FDA UDI
- Description
- Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 2 screw mount design FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZEPAUB520 FDA UDI
- 510(k) Number
- K121929 FDA UDI
- FDA Product Code
- FRZ FDA UDI
- GMDN Term
- Patient lifting system stretcher FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6775 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient lifting system stretcher
Zephyr Patient Positioning and Transfer System by Diacor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient lifting system stretcher.
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- Applicator Clamp Holder — Qfix · Class II
- Rollbord Transglide Patglide — Samarit Medical AG · Class I
- Transa Silber Gleiter M — Transatlantic HG Stolpe & Co. mbH · Class I
Cleared under the same submission
K121929 also covers:
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
- Diacor Inc.
Sources (1)
- FDA UDI 355d20b0-b5c3-4656-aefd-5edd30a1dc17 34 fields · synced May 29, 2026