AccessGUDID - DEVICE: Zephyr Patient Positioning and Transfer System (B237ZBL80)

GUDID

Device Identifier (DI) Information

Brand Name: Zephyr Patient Positioning and Transfer System
Version or Model: ZBL-8
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Diacor, Inc.

Primary DI Number: B237ZBL80
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 110V, 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?
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.	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: 34c85f83-f3aa-42f7-bbe6-2ae7f5356d88
Public Version Date: April 15, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016