Catalog Number

4C2405

Brand Name

Sampling Site Coupler

Version/Model Number

4C2405

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)

Yes

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

-

Product Code

KSS

Product Code Name

Supplies, Blood-Bank

Public Device Record Key

a324a25f-7abe-4337-9de2-454ff2af0ff0

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

24086000903206

Quantity per Package

2

Contains DI Package

14086000903209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton