| Primary Device ID | 00860003258408 |
| NIH Device Record Key | 405dee42-7e07-4595-8ee7-45917e005362 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Frostmed LITE |
| Version Model Number | V 1.0 |
| Company DUNS | 079574775 |
| Company Name | FROSTIME LLC |
| 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 | 1 646-569-5785 |
| info@frostmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003258408 [Primary] |
| KSE | Refrigerator, Freezer, Blood Storage |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-05 |
| Device Publish Date | 2020-01-23 |
| 00860003258408 - Frostmed LITE | 2020-02-05Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App |
| 00860003258408 - Frostmed LITE | 2020-02-05 Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each |
| 00860003258415 - Frostmed PRO | 2020-02-05 Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/ea |