Duns Number:118492643
Device Description: 1 ea - dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe
Catalog Number
20-001
Brand Name
Sentinel Chest Seal
Version/Model Number
03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 17, 2024
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
4b0d5d87-0aba-4f02-b993-79ba0538c136
Public Version Date
April 12, 2022
Public Version Number
3
DI Record Publish Date
October 26, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |