Duns Number:120818216
Device Description: 3 WAY STOPCOCK W/2 BIONECTORS
Catalog Number
BN-3002
Brand Name
VYGON
Version/Model Number
BN-3002
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012157,K012157
Product Code
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
b274451a-5e7c-49d6-af4f-cce616ed3e3b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 07, 2016
Package DI Number
38498840009582
Quantity per Package
50
Contains DI Package
08498840009581
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |