Catalog Number

HM50RPSPU

Brand Name

N/A

Version/Model Number

HM50RPSPU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

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

-

Product Code

FRZ

Product Code Name

DEVICE, PATIENT TRANSFER, POWERED

Public Device Record Key

9f8ede2b-918d-4a2f-aee4-c7845fa9b9a2

Public Version Date

April 28, 2022

Public Version Number

2

DI Record Publish Date

July 10, 2019

Package DI Number

57613327487676

Quantity per Package

5

Contains DI Package

07613327487671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case