FDA.reportPublic FDA data

BresoDX1BresoHub

Primary DI
00990008600015
Brand
BresoDX1BresoHub
Company
BresoTec Inc
Model
BTSM1US-DCU
Catalog number
BT0001-01
Device description
BresoHub is a component of BresoDX1. During a test, BresoHub is placed at the patient’s bedside to receive the data from BresoSensor and the pulse oximeter wirelessly, and it stores the data locally. BresoHub is powered by a provided power supply. This device is only sold USA.
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220012000BresoDX1Bresotec, Inc.2022-12-21MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00990008600015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00990008600015009900086000159900086000150990008600015

GMDN Terms#

Term, Definition table
TermDefinition
Home-use sleep apnoea recording systemA battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203297148
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00990008600039BresoDX1 BresoSensor FrameBTSM1-UF2023-06-27
00990008600022BresoDX1 BresoSensorBTSM1US-URU2023-06-26
00990008600046BresoDX1 Tape StripsBTSM1-BTS2023-06-26
00990008600053BresoDX1 Main KitBTSM1US-DCUURU2023-06-26
00990008600060BresoDX1 Accessory KitBTSM1-UFBTS2023-06-26
00990008600077BresoDX1 Master KitBTSM1US2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413407392Sensor kit for SOMNOscreen (paediatric)SOMNOmedics AGMNR2026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SOMNOmedics AGMNR2026-10-10
04250413402380Pneumatic Effort Belt - Size XSSOMNOmedics AGMNR2026-10-09
04250413402397Pneumatic Effort Belt - Size SSOMNOmedics AGMNR2026-10-09
04250413402403Pneumatic Effort Belt - Size MSOMNOmedics AGMNR2026-10-09
04250413402410Pneumatic Effort Belt - Size LSOMNOmedics AGMNR2026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSOMNOmedics AGMNR2026-10-09
04250413410392Wireless PLM/EMG sensor right legSOMNOmedics AGMNR2026-10-08
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
04250413410385Wireless PLM/EMG sensor left legSOMNOmedics AGMNR2026-10-07
00850063034395Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034500Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034517Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00860000272421Rhythm ExpressVIVAQUANT, INC.MNR2026-10-01
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15