Catalog Number

460830442

Brand Name

Transpac™

Version/Model Number

460830442

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

37a76548-d911-4b18-9eb5-101cfb2eac38

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

10840619069091

Quantity per Package

25

Contains DI Package

00840619069094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS