| Primary Device ID | B285SDSCB2001 |
| NIH Device Record Key | 7ab54a88-6f49-4042-a62a-90158fde7bb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiPro Bicarb Mixing/Distribution System |
| Version Model Number | SDS-CB200 |
| Company DUNS | 926740010 |
| Company Name | MEDICAL SOLUTIONS INTERNATIONAL, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B285SDSCB2001 [Primary] |
| FIN | Tank, Holding, Dialysis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
[B285SDSCB2001]
Hydrogen Peroxide;Ozone
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-30 |