FDA UDI
In Commercial Distribution
🇺🇸 United States
DUPLOCATH
DI: 00085412600048
·
Model: 1506167
·
BAXTER INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DUPLOCATH
- Primary DI
- 00085412600048
- Version / Model
- 1506167
- Catalog Number
- 1506167
- Company Name
- BAXTER INTERNATIONAL INC.
- Labeler DUNS
- 005146311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-28
- Public Version
- 4
- Public Version Date
- 2022-11-03
- Public Version Status
- Update
- Public Device Record Key
- 1ac1ee40-0bd1-44a8-94c4-3a506466ba14
Device Description
Catheter for the simultaneous application of Baxter two-component fibrin sealant in endoscopic surgery. The application of Baxter two-component fibrin sealant can be carried out via a double syringe system and the two-lumen Duplocath application catheter.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44830 | Open-surgery adhesive/sealant applicator, dual-channel | A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20085412600042 | GS1 | BX | 1 | In Commercial Distribution | |
| Primary | 00085412600048 | GS1 | ||||
| Package | 50085412600043 | GS1 | CA | 22 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(888)229-0001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK170033 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 180 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit