Duns Number:072656713
Device Description: SWAT-T Elastic Tourniquet, used to stop or slow severe hemorrhaging from injured limbs and SWAT-T Elastic Tourniquet, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss.
Catalog Number
SWAT-T-BLK-EA
Brand Name
SWAT-T Elastic Tourniquet, Black
Version/Model Number
1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAX
Product Code Name
Tourniquet, Nonpneumatic
Public Device Record Key
538d07f4-66bf-4ce7-94e2-11391f29c1b7
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 31, 2020
Package DI Number
00857048006453
Quantity per Package
100
Contains DI Package
00857048006392
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |