Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012689738

FEI Number

3012689738

Entity Name

AVACORE TECHNOLOGIES, INC.

City/State/Country

Ann Arbor, MI, US

Establishment Address

600 S Wagner Rd, Ann Arbor, MI 48103, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AVAcore Technologies, Inc. (Owner Number: 10054033)

Owner / Operator Contact Address

600 South Wagner, Ann Arbor, MI 48103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040911

PMA Number

N/A

All Registered Proprietary Names

warmUP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2017-02-03

Official Correspondent

Charles Hixson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AVAcore Technologies, Inc.

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 3012689738. Last updated year: 2026. Please use registration number 3012689738 when referencing this establishment in official correspondence.