Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617566

FEI Number

3003244771

Entity Name

BREAS MEDICAL AB

City/State/Country

MOLNLYCKE Vastra Gotaland, SE

Establishment Address

FORETAGSVAGEN 1, MOLNLYCKE Vastra Gotaland 435 33, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Breas Medical (Owner Number: 10046282)

Owner / Operator Contact Address

Foretagsvagen 1, MOLNLYCKE, SE-O SE43533, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242485

PMA Number

N/A

All Registered Proprietary Names

Vivo 45 LS Vivo 45 LS Vivo 3 Vivo 45 LS Vivo 65 Ventilator Trolley Single Patient Breathing Hose, Breathing Therapy Equipment Patient Circuit, Single Limb with Leakage Port, Disposable, B T-Piece US Vivo 1, Vivo 2 EveryWare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2021-02-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-02-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-02-09
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	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	2025-05-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-05-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-05-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-05-20
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2025-05-20
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2025-05-16
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-05-16
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
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	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
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-11-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-11-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2016-11-11
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2016-11-11
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2022-06-17
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2014-02-27
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2014-12-19
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
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
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2025-05-21
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2025-05-21
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2025-05-21

Official Correspondent

No official correspondent registered.

US Agent Details

Ramsey Lancaster Business: Breas Medical Inc Email: FDAtracking@breas.com Phone: (434) 2561049

Related Public Records

Same Entity

Breas Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020562909	Breas Medical Ltd	Stratford-upon-Avon Warwickshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617566. Last updated year: 2026. Please use registration number 9617566 when referencing this establishment in official correspondence.