Duns Number:041674552
Device Description: TrueSafe Comfort with Venapur, Blood Control 16G x 1.77”
Catalog Number
Not Applicable
Brand Name
MedSource Catheters
Version/Model Number
MS-86416
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
-
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
3d2c1a7a-8e91-41b6-b3fd-238335eb2477
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
00840155409620
Quantity per Package
50
Contains DI Package
00840155409606
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 |