Duns Number:094651270
Device Description: DISPOSABLE STOPCOCK, THREE-WAY LUER LOCK, BLUE, STERILE
Catalog Number
400-351
Brand Name
N/A
Version/Model Number
Three-Way
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K861783,K861783
Product Code
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
61397edd-0782-415d-a0f6-57a729c87760
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H6714003511
Quantity per Package
50
Contains DI Package
H6714003510
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |