Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZBL-1-400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 10, 2018

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

9b9d462c-003d-46c5-98c1-8f02e7fba98c

Public Version Date

August 22, 2019

Public Version Number

3

DI Record Publish Date

November 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-