FDA UDI
In Commercial Distribution
🇺🇸 United States
Axius Coronary Shunt
DI: 00607567700642
·
Model: OF-2250
·
MAQUET CARDIOVASCULAR LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Axius Coronary Shunt
- Primary DI
- 00607567700642
- Version / Model
- OF-2250
- Catalog Number
- OF-2250
- 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
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e46dacfd-7b15-4f41-8e2f-34fc51ddb485
Device Description
Axius Coronary Shunt
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 |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47111 | Surgical intravascular shunt | A sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00607567700646 | GS1 | 5 pack box | 5 | Not in Commercial Distribution | 2018-05-29 |
| Primary | 00607567700642 | GS1 | ||||
| Package | 20607567700646 | GS1 | 5 pack box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-880-2874
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010117 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.25 | Millimeter |