Primary Device ID | 00990008600060 |
NIH Device Record Key | 0808be61-7838-4e3b-8c20-2592f64ca910 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BresoDX1 Accessory Kit |
Version Model Number | BTSM1-UFBTS |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00990008600060 [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 | 2023-07-04 Contains BresoHub and BresoSensor; USA Only |
00990008600060 - BresoDX1 Accessory Kit | 2023-07-04Contains BresoSensor Frame (50 units) and BresoTape (100 Units); 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 |