FDA UDI
In Commercial Distribution
🇺🇸 United States
enableCV Retrograde Cardioplegia Catheter
DI: 00840479402079
·
Model: RC014T
·
ENABLECV INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- enableCV Retrograde Cardioplegia Catheter
- Primary DI
- 00840479402079
- Version / Model
- RC014T
- Company Name
- ENABLECV INC.
- Labeler DUNS
- 119247843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-17
- Public Version
- 1
- Public Version Date
- 2026-02-25
- Public Version Status
- New
- Public Device Record Key
- ae3bf09c-d1fa-48ef-90da-95254d472e4d
Device Description
enableCV Retrograde Cardioplegia Catheter
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
- Yes
- 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 |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36109 | Coronary sinus cannula | A sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into the ostium of the coronary sinus to provide retrograde coronary perfusion/cardioplegia during cardiopulmonary bypass or minimally invasive surgery. It may be equipped with a self-inflating low pressure balloon that is typically used for back flushing the coronary vessel in the event of inadvertent coronary air embolization. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840479402086 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00840479402079 | GS1 |
Customer Contacts
- Phone
- +1(888)943-2783
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123187 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14 Fr. (4.7 mm) X 27 cm (10.6") |