DUPLOCATH 1506166
GUDID 50085412600036
Catheter for the simultaneous application of Baxter two-component fibrin sealant in minimally invasive surgery. 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.
BAXTER INTERNATIONAL INC.
Open-surgery adhesive/sealant applicator, dual-channel| Primary Device ID | 50085412600036 |
| NIH Device Record Key | 9e1f4593-aa82-4153-91b5-86014d556e7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUPLOCATH |
| Version Model Number | 1506166 |
| Catalog Number | 1506166 |
| Company DUNS | 005146311 |
| Company Name | BAXTER INTERNATIONAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412600031 [Primary] |
| GS1 | 20085412600035 [Package] Contains: 00085412600031 Package: PACK_OR_INNER_PACK [1 Units] In Commercial Distribution |
| GS1 | 30085412600032 [Package] Contains: 00085412600031 Package: PACK_OR_INNER_PACK [1 Units] In Commercial Distribution |
| GS1 | 50085412600036 [Package] Contains: 00085412600031 Package: CASE [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK170033
- BK170033
FDA Product Code
| FMF | Syringe, piston |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-31 |
| Device Publish Date | 2018-09-28 |
On-Brand Devices [DUPLOCATH]
| 20085412600042 | Catheter for the simultaneous application of Baxter's two-component fibrin sealant in endoscopic |
| 50085412600036 | Catheter for the simultaneous application of Baxter two-component fibrin sealant in minimally in |
| 20085412600028 | Catheter for the simultaneous application of Baxter's two-component fibrin sealant in areas of t |
| 00085412314112 | Duplocath Application Catheter |
| 00085412314105 | Duplocath Application Catheter with M.I.S. Adaptor |
| 00085412095646 | Duplocath Application Catheter |
Trademark Results [DUPLOCATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUPLOCATH 75327893 2312263 Live/Registered |
Baxter International Inc. 1997-07-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.