FDA UDI
In Commercial Distribution
🇺🇸 United States
COSEAL SPRAY SET
DI: 05413765583414
·
Model: 1514243
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- COSEAL SPRAY SET
- Primary DI
- 05413765583414
- Version / Model
- 1514243
- Catalog Number
- 1514243
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 005083209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 5
- Public Version Date
- 2024-04-11
- Public Version Status
- Update
- Public Device Record Key
- 09639216-c653-41c6-9bc1-08c866ca0d72
Device Description
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
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 |
|---|---|---|---|---|
| NBE | Sealant, polymerizing | Unknown | 3 |
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 | 35413765583415 | GS1 | Pack | 10 | In Commercial Distribution | |
| Primary | 05413765583414 | GS1 | ||||
| Package | 55413765583419 | GS1 | Case | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(888)229-0001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030039 | 024 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit