Duns Number:961027315
Device Description: STRAP TOURNIQUET 3/4X18IN LATEX FRE
Catalog Number
CH7067
Brand Name
CARDINAL HEALTH
Version/Model Number
CH7067
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"
-
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
852f7ac6-192f-4524-bb9f-fa591caf69e1
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 04, 2019
Package DI Number
50885380041769
Quantity per Package
4
Contains DI Package
70885380041763
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 | 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 |