Catalog Number

HM34SPU-LNK-B-STB

Brand Name

Sustainable Technologies

Version/Model Number

HM34SPU-LNK-B-STB

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"

-

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

57fb853c-d52f-43ac-ad31-6c4c5771c99b

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-