| Primary Device ID | 10816934022585 |
| NIH Device Record Key | f133f8c5-0877-4aa7-895b-942a673559a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermo Scientific HERAfreeze |
| Version Model Number | HDE60086MA |
| Catalog Number | HDE60086MA |
| Company DUNS | 938286804 |
| Company Name | KEY SCIENTIFIC INC |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 828-658-4400 |
| marilyn.barry@thermofisher.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816934022585 [Primary] |
| KSE | Refrigerator, Freezer, Blood Storage |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-08 |
| Device Publish Date | 2020-04-30 |
| 10816934022608 | Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 230V/50Hz; ENERGY STAR certifie |
| 10816934022592 | Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 208-230V/60Hz; ENERGY STAR cert |
| 10816934022585 | Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 115V/60Hz; ENERGY STAR certifie |