FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartLight
DI: 00868976000109
·
Model: 18-2531-N250
·
CARDIOFOCUS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartLight
- Primary DI
- 00868976000109
- Version / Model
- 18-2531-N250
- Catalog Number
- 18-2531-N250
- Company Name
- CARDIOFOCUS, INC.
- Labeler DUNS
- 068966261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a576b3aa-5bb0-4bcf-9eba-38eff4b3679a
Device Description
Laser Ablation Balloon 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61772 | Cardiac ablation laser system beam guide-catheter | A sterile, flexible, steerable catheter intended to be used as part of a cardiac ablation laser system to invasively direct and deliver laser energy to the endocardium of a beating heart for the ablation of specific areas in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868976000109 | GS1 |
Customer Contacts
- Phone
- +1(844)527-3723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150026 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 107 | Centimeter | |
| Catheter Gauge | 12 | French |