| Primary Device ID | 10858400005104 |
| NIH Device Record Key | eff243f5-85a0-4c0f-bb3c-6990be8d4932 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEG |
| Version Model Number | 510179 |
| Company DUNS | 003255213 |
| Company Name | AMERICAN NATIONAL RED CROSS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 1 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858400005107 [Primary] |
| GS1 | 10858400005104 [Package] Contains: 00858400005107 Package: [5 Units] In Commercial Distribution |
| KSG | Media, Potentiating For In Vitro Diagnostic Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
| 00858400005114 - Red Cell Storage Solution | 2020-07-27 Red Cell Storage Solution is intended for use in the dilution and/or preservation of human red blood cells (RBCs) for the purpos |
| 10858400005104 - PEG | 2018-10-18PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution. |
| 10858400005104 - PEG | 2018-10-18 PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. T |
| 10858400005128 - LISS | 2018-10-18 LISS is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. |
| 00858400005084 - DailyChek QC Kit | 2018-07-06 Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells. |
| 00858400005008 - Anti-K | 2018-03-29 Blood Grouping Reagent |
| 00858400005015 - Anti-k | 2018-03-29 Blood Grouping Reagent |
| 00858400005022 - Anti-Kpa | 2018-03-29 Blood Grouping Reagent |
| 00858400005039 - Anti-Kpb | 2018-03-29 Blood Grouping Reagent |