Catalog Number

-

Brand Name

Extension Set Minibore

Version/Model Number

00853620005524

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

K162601,K162601,K162601

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

dd838862-14e7-4069-961e-0f3865efd396

Public Version Date

February 01, 2019

Public Version Number

1

DI Record Publish Date

January 01, 2019

Package DI Number

20853620005528

Quantity per Package

6

Contains DI Package

10853620005521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-