Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZEP-3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 2021

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121929

Product Code

FRZ

Product Code Name

Device, Patient Transfer, Powered

Public Device Record Key

910a6ac9-1ff5-4814-a17d-d188300008da

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-