Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014426939

FEI Number

3014426939

Entity Name

BRAINCOOL AB

City/State/Country

Lund Skane, SE

Establishment Address

Scheelevagen 2, Lund Skane 22381, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BrainCool AB (Owner Number: 10058195)

Owner / Operator Contact Address

Scheelevagen 2, Lund, SE-M 22381, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN210027

PMA Number

N/A

All Registered Proprietary Names

IQool Warm System The Cooral System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2018-07-26
QUA	Intraoral Cooling Device	Dental	Class 2	872.5590	2022-12-19

Official Correspondent

Hakan Hummet

US Agent Details

Adam Harris Business: Target Health Email: aharris@targethealth.com Phone: (646) 4792437

Related Public Records

Same Entity

BrainCool AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number	Establishment Name	Location
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
2432320	NOVAMED-USA	Elmsford, NY, US
3012315097	CARE ESSENTIALS INTERNATIONAL PVT LTD.	Ahmedabad Gujarat, IN
9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014426939. Last updated year: 2026. Please use registration number 3014426939 when referencing this establishment in official correspondence.