Duns Number:961027315
Device Description: Strap Tourniquet; Latex Free; Orange Smooth Perforated Roll
Catalog Number
CH8079
Brand Name
CARDINAL HEALTH
Version/Model Number
CH8079
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 08, 2023
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
-
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
d17f829d-2f9e-421d-808e-3fa22c63b033
Public Version Date
February 09, 2022
Public Version Number
2
DI Record Publish Date
April 29, 2019
Package DI Number
50885380041752
Quantity per Package
20
Contains DI Package
20885380041751
Package Discontinue Date
February 08, 2023
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |