Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010817335

FEI Number

3010817335

Entity Name

BREAS MEDICAL, INC.

City/State/Country

N Billerica, MA, US

Establishment Address

16 Esquire Road, N Billerica, MA 01862, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BREAS MEDICAL, INC. (Owner Number: 10046641)

Owner / Operator Contact Address

16 Esquire Road, N Billerica, MA 01862, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vivo 45 LS Vivo Accessories EveryWare Z2 Vivo Trolley and Accessories Vivo 45LS Vivo 65 Z1 Clearo Clearo Patient Circuit Americas Vivo 1, Vivo 2 Vivo Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-04-10
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-04-10
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2026-04-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-10
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2026-04-10
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2018-04-05
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2025-05-21
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2025-05-21
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2025-05-21
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2025-05-21
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-05-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-12-11
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2022-06-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2021-02-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-02-09
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-02-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-02-09
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2021-02-09
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2022-06-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-06-09
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2022-06-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-06-09
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-04-21
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2025-05-20
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2025-05-16
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2025-05-16
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2018-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BREAS MEDICAL, 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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3038913749	INVENTEUR, LLC	Saint Petersburg, FL, US
3010427901	CMI Health, Inc.	Alpharetta, GA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010817335. Last updated year: 2026. Please use registration number 3010817335 when referencing this establishment in official correspondence.