Duns Number:316153865
Device Description: Venous Catheter, two-stage, SLIM, complete reinforcement, Lighthouse tip, with connector
Catalog Number
70100.5720
Brand Name
NA
Version/Model Number
Ven.Cath.,2-stage,reinf.,Lighthouse tip
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2020
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
K013944,K013944
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
903f5f63-b3d8-42d5-948a-66053b1669f2
Public Version Date
August 05, 2022
Public Version Number
6
DI Record Publish Date
October 24, 2015
Package DI Number
04037691080260
Quantity per Package
10
Contains DI Package
04037691085036
Package Discontinue Date
January 31, 2020
Package Status
Not 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |