BresoDX1 BresoSensor Frame

GUDID 00990008600039

BresoSensor Frame is a biocompatible component. BresoSensor Frame is a plastic holder with a medical grade adhesive on the patient’s contact side. BresoSensor Frame is used to hold BresoSensor on the suprasternal notch. During a test, BresoSensor Frame is intended to be in contact with the patient’s skin for a maximum period of 8 hours.

BresoTec Inc

Home-use sleep apnoea recording system

• Primary Device ID: 00990008600039
• NIH Device Record Key: f77e8c47-44a4-464d-8067-7cfad2594941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BresoDX1 BresoSensor Frame
• Version Model Number: BTSM1-UF
• Company DUNS: 203297148
• Company Name: BresoTec Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00990008600039 [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: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by BresoTec Inc

• 00990008600039 - BresoDX1 BresoSensor Frame: 2023-07-05BresoSensor Frame is a biocompatible component. BresoSensor Frame is a plastic holder with a medical grade adhesive on the patient’s contact side. BresoSensor Frame is used to hold BresoSensor on the suprasternal notch. During a test, BresoSensor Frame is intended to be in contact with the patient’s skin for a maximum period of 8 hours.
• 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: 2023-07-04 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