Catalog Number

SVTS

Brand Name

Swabbable Valve Transfer Set

Version/Model Number

SVTS

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

-

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

K031808,K031808

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

bef2dbf7-c76d-48c8-8ec1-dc0c2f6d0f05

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 25, 2019

Package DI Number

40616258022053

Quantity per Package

50

Contains DI Package

00616258022055

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-