Duns Number:140727624
Device Description: Stopcocks. One Way Stopcock W/Male Luer Lock. Ports Without covers.
Catalog Number
041216810A
Brand Name
STOPCOCKS
Version/Model Number
041216810A
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
K770383,K770383
Product Code
KOC
Product Code Name
Accessories, Blood Circuit, Hemodialysis
Public Device Record Key
d5cf9729-4e06-40b8-a445-d4913755e26f
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 23, 2015
Package DI Number
20886333201437
Quantity per Package
500
Contains DI Package
00886333201433
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |