Catalog Number

HM34SPU-B

Brand Name

N/A

Version/Model Number

HM34SPU-B

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

659b03b4-25e5-465e-9963-febea5274dbc

Public Version Date

April 28, 2022

Public Version Number

2

DI Record Publish Date

July 10, 2019

Package DI Number

57613327487591

Quantity per Package

10

Contains DI Package

07613327487596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case