FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DLP® Aortic Root Cannula with Flow-Guard™
DI: 00673978861487
·
Model: CB11012
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DLP® Aortic Root Cannula with Flow-Guard™
- Primary DI
- 00673978861487
- Version / Model
- CB11012
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d0833dd7-a82c-46da-a906-f6f0cac45126
- Distribution End Date
- 2017-11-30
Device Description
CANNULA CB11012 AR FLOWGUARD 12GA 10L
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47799 | Cardioplegia cannula | A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673978861487 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K790565 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 9.0 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius