| Primary Device ID | 00085412479194 | 
| NIH Device Record Key | a80c81ed-8b79-43fd-a006-520793332ea4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EXACTAMIX | 
| Version Model Number | H9382400-DYR | 
| Catalog Number | 2400DYR | 
| Company DUNS | 078383477 | 
| Company Name | BAXTER CORPORATION ENGLEWOOD | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)933-0303 | 
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | |
| Phone | +1(800)678-2292 | 
| COTechSupport@baxter.com | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between 0 Degrees Celsius and 64 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00085412479194 [Primary] | 
| NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-23 | 
| 50085412492112 | EXACTAMIX 2400 Valve Set, 24-Port Valve Assembly | 
| 50085412492051 | EXACTAMIX Inlet, Vented, Micro-Volume Inlet | 
| 50085412492006 | EXACTAMIX 1200 Valve Set, 12-Port Valve Assembly | 
| 00085412486253 | EXACTAMIX Compounder, Long Vial Rack, Short Rods | 
| 00085412486246 | EXACTAMIX Compounder, Vial Rack, Short Rods | 
| 00085412486222 | EXACTAMIX Compounder, Vial Rack, Long | 
| 00085412486215 | EXACTAMIX Compounder, Vial Rack | 
| 00085412482828 | EXACTAMIX Compounder, EM1200 Refurbished Display | 
| 00085412482644 | EXACTAMIX Compounder, Main Module Refurbished Unit | 
| 00085412482637 | EXACTAMIX Compounder, Main Module | 
| 00085412482620 | EXACTAMIX Compounder, Load Cell Module Refurbished Unit | 
| 00085412482613 | EXACTAMIX Compounder, Load Cell Module | 
| 00085412482569 | EXACTAMIX Compounder, Base Plate Module | 
| 50085412480072 | EXACTAMIX Connector, Tube Set Calibration Extension | 
| 00085412479194 | EXACTAMIX Compounder, EM2400 Refurbished Display | 
| 00085412477572 | EXACTAMIX Compounder, EM1200 Display | 
| 50085412477478 | EXACTAMIX EVA - Dual Chamber Empty Container | 
| 50085412477461 | EXACTAMIX Empty EVA Dual Chamber Container With Screw Connectors | 
| 50085412477300 | EXACTAMIX 1200 Valve Set, 12-Port Valve Assembly | 
| 50085412477294 | EXACTAMIX Inlet, Vented, Micro-Volume Inlet | 
| 50085412477270 | EVA Container 5000mL | 
| 50085412477263 | EVA Container 4000mL | 
| 50085412477256 | EVA Container 3000mL | 
| 50085412477249 | EVA Container 2000mL | 
| 50085412477232 | EVA Container 1000mL | 
| 50085412477225 | EVA Container 500mL | 
| 50085412477218 | EVA Container 250mL | 
| 50085412477201 | 1000mL Calibration Bag | 
| 50085412477188 | EXACTAMIX 2400 Valve Set, 24-Port Valve Assembly | 
| 50085412476716 | EXACTAMIX Adapter, Bag Adapter, with Blunt Spike | 
| 50085412476709 | EXACTAMIX Connector, Tube Set Extension Piece | 
| 50085412475818 | EXACTAMIX Inlet, Syringe Inlet | 
| 50085412475801 | EXACTAMIX Inlet, Vented, Micro-Volume Inlet | 
| 50085412475795 | EXACTAMIX Inlet, Vented, High-Volume Inlet | 
| 50085412475788 | EXACTAMIX Inlet, Non-Vented, High-Volume Inlet | 
| 50085412475771 | European EXACTAMIX 2400 Valve Set, 24-Port Valve Assembly | 
| 55413765562735 | EXACTAMIX Adapter, Needle Port Adapter | 
| 55413765492049 | EXACTAMIX Inlet, Syringe Inlet | 
| 55413765492032 | EXACTAMIX Inlet, Vented, Micro-Volume Inlet | 
| 55413765492025 | EXACTAMIX Inlet, Vented, High-Volume Inlet | 
| 55413765492018 | EXACTAMIX Inlet, Non-Vented, High-Volume Inlet | 
| 05413765477584 | EXACTAMIX Compounder, EM2400 Display | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EXACTAMIX  86691123  4939958 Live/Registered | Baxter Corporation Englewood 2015-07-13 | 
|  EXACTAMIX  85032769  3893799 Live/Registered | BAXTER CORPORATION ENGLEWOOD 2010-05-07 |