FDA Registration
Active
🇺🇸 United States
IntraTemp ThermaBasin
Reg #: 1417592
·
FEI: 1417592
·
Expires 2025
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MEDLINE INDUSTRIES, LP - Northfield
- Registration Number
- 1417592
- FEI Number
- 1417592
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- ZIP
- 60093
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201290
Owner / Operator
- Firm Name
- Medline Industries, LP
- Operator Number
- 1417592
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- Postal Code
- 60093
- Country
- US
- Correspondent
- Stephanie Augsburg
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2021-04-14 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2021-04-14 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2021-04-14 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2021-04-14 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-04-14 |
Proprietary Names
IntraTemp ThermaBasin
CoreTemp Surgical Solution Warming System
Medline DeNovo 4Pro Electrical Stimulation Device
Hush-Slush Consoles
Ecolab Fluid Warmer
ORS Solution Warmers
IntraTemp Fluid Warming System
Fluid Warming and Surgical Slush
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility