FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartLight
DI: 00868976000130
·
Model: 18-1342
·
CARDIOFOCUS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartLight
- Primary DI
- 00868976000130
- Version / Model
- 18-1342
- Catalog Number
- 18-1342
- 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
- 70f44d2c-d4ed-48c9-8cda-4d88faaa68e5
Device Description
Balloon Fill Media
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 61970 | Vascular balloon catheter fill-media | A dedicated sterile solution (e.g., deuterium oxide) intended to be pumped into an appropriate vascular balloon catheter (e.g., cardiac laser system beam guide-catheter with balloon tip) to inflate the distal balloon during a vascular procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868976000130 | GS1 |
Customer Contacts
- Phone
- +1(844)527-3723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150026 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 95 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius