| Primary Device ID | 00817955020010 |
| NIH Device Record Key | 7be1633a-fd01-41f7-8cfc-34fd2be3dcf9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SGP (Plasma Management System) |
| Version Model Number | 7 |
| Company DUNS | 189578800 |
| Company Name | BIOMAT USA, 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00817955020010 [Primary] |
| MMH | Blood Establishment Computer Software And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-31 |
| Device Publish Date | 2018-12-31 |
| 00817955020003 - GDS (Grifols Donation System) | 2019-01-31 GDS (acronym for Grifols Donation System) is an application designed to manage plasma donor center activities such as donor elig |
| 00817955020010 - SGP (Plasma Management System) | 2019-01-31SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units. |
| 00817955020010 - SGP (Plasma Management System) | 2019-01-31 SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics o |