Catalog Number

B912601

Brand Name

Primary Sets

Version/Model Number

B912601

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

K142367,K142367

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

218748dd-1fa5-4890-8a65-19294f9fff43

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

June 04, 2018

Package DI Number

20887787009303

Quantity per Package

50

Contains DI Package

10887787009306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box