Duns Number:926603486
Device Description: a device for stopping the flow of blood through a vein or artery, typically by compressing a device for stopping the flow of blood through a vein or artery, typically by compressing a limb with a cord or tight bandage.
Catalog Number
DU2210
Brand Name
Tourniquet 1"x18"
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)
-
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
912fef56-0339-4854-8cd1-bce836f126af
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 06, 2020
Package DI Number
10850014433229
Quantity per Package
250
Contains DI Package
00850014433222
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |