FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartLight
DI: 00868976000123
·
Model: 18-1447
·
CARDIOFOCUS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartLight
- Primary DI
- 00868976000123
- Version / Model
- 18-1447
- Catalog Number
- 18-1447
- 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
- c2ffcece-aa89-407a-9933-a436c86c9bfa
Device Description
Endoscope
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 34855 | Flexible fibreoptic arterioscope, reusable | An endoscope with a very thin, flexible inserted portion intended for the visual examination and some treatment of coronary arteries, peripheral vessels, and intracardiac structures. It is inserted into the body through a surgically-created orifice during arterioscopy. Anatomical images are transmitted to the user through a fibreoptic bundle (e.g., a fused silica flexible rod that provides sharper images and greater strength). This device is intended to be used to examine arteries and arterial circulation; blood flow is normally blocked in the arteries by a balloon while a clear liquid is infused to flush away residual blood to provide a clear view. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868976000123 | GS1 |
Customer Contacts
- Phone
- +1(844)527-3723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150026 | 000 |