Duns Number:196548481
Device Description: Disposable Tourniquet Cuff Single Bladder, Single Port and Luer Lock Connector
Catalog Number
5921-218-136
Brand Name
Color Cuff
Version/Model Number
5921218136
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCY
Product Code Name
TOURNIQUET, PNEUMATIC
Public Device Record Key
d4bea65a-33ad-4340-8795-8ced6a6ca2eb
Public Version Date
August 30, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
37613154599746
Quantity per Package
10
Contains DI Package
07613154599745
Package Discontinue Date
December 31, 2020
Package Status
Not in Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |