Duns Number:238476068
Device Description: Occlusive dressings for open chest wounds. For use by emergency trained responders (CE& US Occlusive dressings for open chest wounds. For use by emergency trained responders (CE& US Swedish/ Norwegian/English Pack)
Catalog Number
FG08814621
Brand Name
FOXSEAL
Version/Model Number
FG08814621
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)
-
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
dab9aa84-7659-4c5c-9452-23f3a350be0d
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
Package DI Number
75060206631365
Quantity per Package
100
Contains DI Package
15060206631363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| U | Unclassified | 14 |