FDA UDI
In Commercial Distribution
🇺🇸 United States
enableCV EZ Glide™ Aortic Cannula
DI: 00840479400815
·
Model: EZF24TA
·
ENABLECV INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- enableCV EZ Glide™ Aortic Cannula
- Primary DI
- 00840479400815
- Version / Model
- EZF24TA
- Company Name
- ENABLECV INC.
- Labeler DUNS
- 119247843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-18
- Public Version
- 1
- Public Version Date
- 2026-02-26
- Public Version Status
- New
- Public Device Record Key
- 9c71ec37-e285-4ea1-8cae-e9a6231886e8
Device Description
enableCV EZ Glide™ Aortic Cannula - EZF24TA
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 |
|---|---|---|---|---|
| 34893 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return | A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840479400822 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00840479400815 | GS1 |
Customer Contacts
- Phone
- 1(888)943-2783
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123370 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 24 Fr. (8.0 mm) X 37.6 cm (14.8") |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store sterile packaged device in a cool, dry place.