| Primary Device ID | M74430001 |
| NIH Device Record Key | d717e357-47c5-492c-94b2-41c2e048f30e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemoTemp II |
| Version Model Number | 3000 |
| Company DUNS | 070698154 |
| Company Name | BIOSYNERGY, INC. |
| Device Count | 40 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | M74430000 [Unit of Use] |
| HIBCC | M74430001 [Primary] |
| HIBCC | M74430002 [Package] Package: Case [5 Units] In Commercial Distribution |
| KSS | Supplies, Blood-Bank |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-03-01 |
| Device Publish Date | 2017-02-08 |
| M74420002 - HemoTemp | 2022-05-12 |
| M74450002 - StaFreez | 2022-05-12 |
| M74481001 - HemoCool Gel-Pak | 2022-05-12 |
| M74490001 - HemoTemp II Activator | 2022-05-12 |
| M74430001 - HemoTemp II | 2021-03-01 |
| M74430001 - HemoTemp II | 2021-03-01 |
| M74460002 - LabTemp 20 | 2021-03-01 |
| M74461001 - LabTemp 40 | 2021-03-01 |
| M74410002 - TempTrend | 2020-02-24 |