Duns Number:140727624
Device Description: Contrast Line 10"(25cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI
Catalog Number
193362
Brand Name
Contrast Line
Version/Model Number
193362
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
K963749,K963749
Product Code
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
e26640fb-75f4-4d6b-adaf-dfd2ee21d3d2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
20886333207460
Quantity per Package
25
Contains DI Package
00886333207466
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 |