| Primary Device ID | 00817492022348 |
| NIH Device Record Key | c3c5900f-48ba-4b11-b695-2cee152cda63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioPure 4400 RO |
| Version Model Number | 95M16B2E |
| Company DUNS | 019056181 |
| Company Name | MAR COR PURIFICATION, 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 | true |
| 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 |
| Phone | 8002685035 |
| orderdesk@mcpur.com |
| Weight | 764 Pound |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817492022348 [Primary] |
| FIP | Subsystem, Water Purification |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2019-01-30 |