| Primary Device ID | M74420002 |
| NIH Device Record Key | 4afb8512-4892-4975-8b8e-f7947325cfbb |
| Commercial Distribution Discontinuation | 2022-02-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HemoTemp |
| Version Model Number | 2000 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com | |
| Phone | 800-255-5274 |
| jaddis@biosynergyinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M74420000 [Unit of Use] |
| HIBCC | M74420001 [Primary] |
| HIBCC | M74420002 [Package] Contains: M74420001 Package: Case [5 Units] Discontinued: 2022-02-12 Not in Commercial Distribution |
| 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 | 5 |
| Public Version Date | 2022-05-12 |
| Device Publish Date | 2016-09-01 |
| M74420002 - HemoTemp | 2022-05-12 |
| 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 |
| M74460002 - LabTemp 20 | 2021-03-01 |
| M74461001 - LabTemp 40 | 2021-03-01 |
| M74410002 - TempTrend | 2020-02-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEMOTEMP 73426709 1320144 Live/Registered |
Biosynergy, Inc. 1983-05-19 |