FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Zephyr Patient Positioning and Transfer System
DI: B237ZBL14000
·
Model: ZBL-1-400
·
Diacor, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zephyr Patient Positioning and Transfer System
- Primary DI
- B237ZBL14000
- Version / Model
- ZBL-1-400
- Company Name
- Diacor, Inc.
- Labeler DUNS
- 605813559
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-09
- Public Version
- 4
- Public Version Date
- 2023-06-14
- Public Version Status
- Update
- Public Device Record Key
- 9b9d462c-003d-46c5-98c1-8f02e7fba98c
- Distribution End Date
- 2018-11-10
Device Description
Zephyr Blower Kit for 110-120v, equipment boom mount
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 37160 | Patient transfer system, powered | A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B237ZBL14000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121929 | 000 |