Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1836518

FEI Number

3003261020

Entity Name

3T Medical Systems Inc.

City/State/Country

Edison, NJ, US

Establishment Address

236 Fernwood Ave, Edison, NJ 08837, US

Establishment Type(s)

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

Owner / Operator

3T MEDICAL SYSTEMS, Inc (Owner Number: 9043935)

Owner / Operator Contact Address

236 Fernwood Ave, Edison, NJ 08837, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152266

PMA Number

N/A

All Registered Proprietary Names

ConstaVac CBC ll Blood Conservation Kit Ambulating Bulb Altrix Temperature Management Wraps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2018-09-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-06-20
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-06-20

Official Correspondent

Erica Franco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

3T MEDICAL SYSTEMS, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1226769	ENTERIX INC.	EDISON, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

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
9611109	LivaNova Deutschland GmbH	MUNCHEN Bavaria, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL
3007923088	Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, MY
9680841	SORIN GROUP ITALIA S.R.L	MIRANDOLA Modena, IT
3006654680	Miller Technical Services	Plymouth, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1836518. Last updated year: 2026. Please use registration number 1836518 when referencing this establishment in official correspondence.