FDA UDI
In Commercial Distribution
🇺🇸 United States
Zephyr Patient Positioning and Transfer System
DI: B237ZEPAAS010
·
Model: ZEP-AAS-01
·
Diacor, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zephyr Patient Positioning and Transfer System
- Primary DI
- B237ZEPAAS010
- Version / Model
- ZEP-AAS-01
- Company Name
- Diacor, Inc.
- Labeler DUNS
- 605813559
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-21
- Public Version
- 3
- Public Version Date
- 2025-04-15
- Public Version Status
- Update
- Public Device Record Key
- de8c1a1c-f86a-4e2a-8446-5cd658647721
Device Description
Zephyr HDR Accessory - Arcoma Table Kit. Includes end stop and extended guide rails for use with Arcoma Imaging Table and BodyTom Mobile CT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRZ | Device, Patient Transfer, Powered | General Hospital | 880.6775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40536 | Patient lifting system stretcher | A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. It is designed as an elongated framework with a solid or soft surface upon which the person to be lifted is placed and contained during the lifting process. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B237ZEPAAS010 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121929 | 000 |