Catalog Number

460880422

Brand Name

Transpac™

Version/Model Number

460880422

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

K052828,K052828

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Public Device Record Key

34e20f7a-a022-432a-ad1a-d3ff457448c7

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

10840619069015

Quantity per Package

20

Contains DI Package

00840619069018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS