Duns Number:043537671
Device Description: TUFTS Central line Dressing Change Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
HCT6625TC-A
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
-
Product Code
PEZ
Product Code Name
Central Venous Catheter Dressing Change Kit
Public Device Record Key
a83b3529-009a-431c-86f1-1e272eaf30f9
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
July 13, 2020
Package DI Number
M752HCT6625TCA5
Quantity per Package
30
Contains DI Package
M752HCT6625CTA0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |