FDA Registration
Active
🇺🇸 United States
HEALTH LINE INTERNATIONAL CORPORATION
Reg #: 3010882065
·
FEI: 3006097687
·
Expires 2026
Products
12
Proprietary Names
17
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- HEALTH LINE INTERNATIONAL CORPORATION
- Registration Number
- 3010882065
- FEI Number
- 3006097687
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 260 North Ace Yeager Court, Unit D
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130851
Owner / Operator
- Firm Name
- HEALTH LINE INTERNATIONAL CORPORATION
- Operator Number
- 9096670
- Address
- 260 North Ace Yeager Court, Unit D
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84116
- Country
- US
- Correspondent
- Daniel A Caycho
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2016-10-13 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2010-09-14 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2017-03-01 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2015-06-15 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-12-05 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2018-02-07 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2017-09-22 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2016-08-04 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-08-04 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2023-01-17 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2017-09-27 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2021-01-11 |
Proprietary Names
Cascade
Synergy PICC
Dark Blue DulaCap IV Pole Strip
Uni-Cap
IV Administration Set with Check Valve
DulaCap IV Pole Strip
PIV
Suture Wing
Dark Blue DualCap
Artline
Health Line CT CVC
Health Line CT Midline Catheter
Light Blue DualCap Solo
IV Administration Set
Acute Triple Lumen Hemodialysis Catheter
Trim Tool
Acute Dual Lumen Hemodialysis Catheter
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only