Duns Number:041674552
Device Description: ClearSafe IV Catheter (PTFE) 16g x 1 1/4
Catalog Number
-
Brand Name
MedSource ClearSafe IV Catheter (PTFE) 16g x 1 1/4
Version/Model Number
MS-84116
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"
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
-
Product Code
FOZ
Product Code Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Public Device Record Key
6e01c70a-94a1-4d36-b30d-14effa5d1bb5
Public Version Date
September 22, 2021
Public Version Number
5
DI Record Publish Date
June 24, 2016
Package DI Number
10816703020538
Quantity per Package
50
Contains DI Package
00816703020531
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |