Duns Number:005146311
Device Description: Catheter for the simultaneous application of Baxter's two-component fibrin sealant in area Catheter for the simultaneous application of Baxter's two-component fibrin sealant in areas of the operation site where access is difficult. The Application of Baxter's two-component fibrin sealant can be carried out via a double syringe system and the two-lumen Duplocath application catheter
Catalog Number
1506165
Brand Name
DUPLOCATH
Version/Model Number
1506165
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
BK170033,BK170033,BK170033
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
96b43f6d-247a-495b-91d0-baf3691f2bc9
Public Version Date
October 19, 2022
Public Version Number
4
DI Record Publish Date
September 28, 2018
Package DI Number
20085412600028
Quantity per Package
1
Contains DI Package
00085412600024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |