FDA UDI
In Commercial Distribution
🇺🇸 United States
Vasoshield
DI: 00607567700468
·
Model: VH-5001
·
MAQUET CARDIOVASCULAR LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vasoshield
- Primary DI
- 00607567700468
- Version / Model
- VH-5001
- Catalog Number
- VH-5001
- Company Name
- MAQUET CARDIOVASCULAR LLC
- Labeler DUNS
- 022348156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- d3327ffb-963a-45a3-b776-7a243224e697
Device Description
Vasoshield Pressure Controlling Syringe
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
- No
- 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 |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47798 | Vascular irrigation cannula, cardiac vessel graft | A sterile, single-lumen, tubular device designed to be used during cardiac surgery to flush an autologous graft, typically a section of explanted saphenous vein, to test its integrity and the closure of lateral vessels, as well as to remove debris and clots after resection. It is typically made of plastic material (e.g., polypropylene) and typically designed with a connector at the proximal end (e.g., is attached to a syringe with a Luer connector) and a ribbed flange at the distal end for a secure connection to the vessel. It may also be used to perfuse the heart through the graft after having done the anastomosis on the coronary artery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00607567700462 | GS1 | 5 pack box | 5 | Not in Commercial Distribution | 2018-05-29 |
| Primary | 00607567700468 | GS1 | ||||
| Package | 20607567700462 | GS1 | 5 pack box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-880-2874
- [email protected]