Catalog Number

-

Brand Name

SAM Chest Seal

Version/Model Number

CS201-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

K102403,K102403

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

45967a0d-534d-4b77-99f8-a9c81939a5ce

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

20822045000173

Quantity per Package

50

Contains DI Package

00822045000179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case