Catalog Number

27TS-EN

Brand Name

SteriPath Gen2, Luer, TS

Version/Model Number

27TS-EN

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

K192247,K192247

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

d890cc1b-ef77-41cd-afbc-fac215f6f738

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Package DI Number

10858366007181

Quantity per Package

10

Contains DI Package

00858366007184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sales Pack