Catalog Number

-

Brand Name

07103300/S

Version/Model Number

07103300/S

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

K852605,K852605,K852605

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

2f519e38-d017-4e43-9f4d-15ffa038358f

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

March 03, 2016

Package DI Number

18053323800016

Quantity per Package

100

Contains DI Package

08053323800019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-