Catalog Number

-

Brand Name

Zephyr Patient Positioning and Transfer System

Version/Model Number

ZBL-1-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

2ab67a7d-f2de-4148-aced-5dbb175baa83

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-