AccessGUDID - DEVICE: Zephyr Patient Positioning and Transfer System (B237ZBL90)

GUDID

Device Identifier (DI) Information

Brand Name: Zephyr Patient Positioning and Transfer System
Version or Model: ZBL-9
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Diacor, Inc.

Primary DI Number: B237ZBL90
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 605813559 *Terms of Use

Device Description: Zephyr Blower Kit for 220v for ZTG-4 stretcher

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: adf6da4d-9095-490f-a5d7-87d06ab0590b
Public Version Date: June 14, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016