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
Stimulator, Electrical, Non-Implantable, For Incontinence KPI
Stimulator, Neuromuscular, External Functional GZI
Device, Biofeedback HCC
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Stimulator, Muscle, Powered IPF

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