Catalog Number

410195

Brand Name

CPS H. Lee SafeSheath® Sealing Adapter

Version/Model Number

00884450505397

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

73070c50-a972-41ba-a40f-6d84b99a60dc

Public Version Date

August 19, 2021

Public Version Number

1

DI Record Publish Date

August 11, 2021

Package DI Number

10884450505394

Quantity per Package

5

Contains DI Package

00884450505397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-