EXACTAMIX H938174
GUDID 50085412475795
EXACTAMIX Inlet, Vented, High-Volume Inlet
BAXTER CORPORATION ENGLEWOOD
Compounding transfer set| Primary Device ID | 50085412475795 |
| NIH Device Record Key | e56b271f-480a-43ca-a79f-6d07af074d16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXACTAMIX |
| Version Model Number | H938174 |
| Catalog Number | H938174 |
| Company DUNS | 078383477 |
| Company Name | BAXTER CORPORATION ENGLEWOOD |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412475790 [Primary] |
| GS1 | 50085412475795 [Package] Contains: 00085412475790 Package: CASE [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K002705
FDA Product Code
| NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [EXACTAMIX]
| 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 |
Trademark Results [EXACTAMIX]
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 |
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