AccessGUDID - DEVICE: Zephyr Patient Positioning and Transfer System (B237ZEPAAS010)

GUDID

Device Identifier (DI) Information

Brand Name: Zephyr Patient Positioning and Transfer System
Version or Model: ZEP-AAS-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diacor, Inc.

Primary DI Number: B237ZEPAAS010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605813559 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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: de8c1a1c-f86a-4e2a-8446-5cd658647721
Public Version Date: April 15, 2025
Public Version Number: 3
DI Record Publish Date: December 21, 2021