DEVICE: Zephyr Patient Positioning and Transfer System (B237ZXL10)
Device Identifier (DI) Information
Zephyr Patient Positioning and Transfer System
ZXL-1
Not in Commercial Distribution
Diacor, Inc.
ZXL-1
Not in Commercial Distribution
Diacor, Inc.
Zephyr XL Patient Hover Board
Device Characteristics
MR Safe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRZ | Device, Patient Transfer, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121929 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
afce138b-4e20-4769-8d1b-7628b2244bc6
June 14, 2023
5
September 24, 2016
June 14, 2023
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined