HemoTemp
GUDID M74420002
BIOSYNERGY, INC.
Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical Medical product temperature point indicator, thermochemical| 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 |
Customer Support Contacts
| 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 Identifiers
| 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 |
FDA Product Code
| KSE | Refrigerator, Freezer, Blood Storage |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-05-12 |
| Device Publish Date | 2016-09-01 |
Devices Manufactured by BIOSYNERGY, INC.
| 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 |
Trademark Results [HemoTemp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOTEMP 73426709 1320144 Live/Registered |
Biosynergy, Inc. 1983-05-19 |
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