Duns Number:020198912
Device Description: Tourniquet Color Cuff Single Port, Single Bladder (Pink), Quick Connect
Catalog Number
5921-115-135RP
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
008ed771-ed76-4ca3-89d0-497700c4d5d3
Public Version Date
August 12, 2019
Public Version Number
1
DI Record Publish Date
August 04, 2019
Package DI Number
57613327384234
Quantity per Package
10
Contains DI Package
07613327384239
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 |