FDA UDI
In Commercial Distribution
🇺🇸 United States
Duploject Easy Prep
DI: 00085412095837
·
Model: 1501250
·
BAXTER INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Duploject Easy Prep
- Primary DI
- 00085412095837
- Version / Model
- 1501250
- Catalog Number
- 1501250
- Company Name
- BAXTER INTERNATIONAL INC.
- Labeler DUNS
- 005146311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7adb8e1c-8d19-476e-812e-f769e54eba23
Device Description
Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (2 mL Kit)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 | 50085412095832 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 00085412095837 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020666 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2 | Milliliter |