Duns Number:621904622
Device Description: The LIFE™ Pack, Advanced, includes the crucial medical supplies, including hemostatic dres The LIFE™ Pack, Advanced, includes the crucial medical supplies, including hemostatic dressing and a twin pack of chest seals, to quickly control moderate to severe bleeding.
Catalog Number
09022
Brand Name
Chinook LIFE Pack, Advanced, SOFTT-W Tourniquet
Version/Model Number
09022
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
17f25acb-2660-485c-af1a-c8f0ad1ae70d
Public Version Date
May 22, 2020
Public Version Number
1
DI Record Publish Date
May 14, 2020
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |