Duns Number:020198912
Device Description: Tourniquet Color Cuff Single Port, Single Bladder (Red), Luer-Lock
Catalog Number
5921-218-136
Brand Name
N/A
Version/Model Number
N/A
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)
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
4f0a16fa-f168-4e78-97bd-9e2ec525d530
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
50885825016512
Quantity per Package
10
Contains DI Package
00885825016517
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 | 304 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
| U | Unclassified | 12 |