BresoDX1BresoHub BT0001-01

GUDID 00990008600015

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.

BresoTec Inc

Home-use sleep apnoea recording system

• Primary Device ID: 00990008600015
• NIH Device Record Key: 7c05e956-aa47-480a-9ba2-5a0a2ea012e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BresoDX1BresoHub
• Version Model Number: BTSM1US-DCU
• Catalog Number: BT0001-01
• Company DUNS: 203297148
• Company Name: BresoTec Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00990008600015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220012

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by BresoTec Inc

• 00990008600039 - BresoDX1 BresoSensor Frame: 2023-07-05 BresoSensor Frame is a biocompatible component. BresoSensor Frame is a plastic holder with a medical grade adhesive on the patie
• 00990008600015 - BresoDX1BresoHub: 2023-07-04BresoHub 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.
• 00990008600015 - BresoDX1BresoHub: 2023-07-04 BresoHub is a component of BresoDX1. During a test, BresoHub is placed at the patient’s bedside to receive the data from Breso
• 00990008600022 - BresoDX1 BresoSensor: 2023-07-04 BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects
• 00990008600046 - BresoDX1 Tape Strips: 2023-07-04 Oximeter Medical Tape Strip is used to maintain the proper placement of the Oximeter Reusable Soft Sensor on the finger. In ever
• 00990008600053 - BresoDX1 Main Kit: 2023-07-04 Contains BresoHub and BresoSensor; USA Only
• 00990008600060 - BresoDX1 Accessory Kit: 2023-07-04 Contains BresoSensor Frame (50 units) and BresoTape (100 Units); USA only
• 00990008600077 - BresoDX1 Master Kit: 2023-07-04 Contains Main Kit, Accessory Kit, and Nonin Pulse Oximeter, USA only