| Primary Device ID | 00990008600053 |
| NIH Device Record Key | bafe7f08-f9ec-4d55-bb45-3f47b4396b46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BresoDX1 Main Kit |
| Version Model Number | BTSM1US-DCUURU |
| 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 | true |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00990008600053 [Primary] |
| MNR | Ventilatory Effort Recorder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
| 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 | 2023-07-04Contains BresoHub and BresoSensor; USA Only |
| 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 |