| Primary Device ID | 20634624501007 |
| NIH Device Record Key | 59523eed-d70f-40e7-836a-1785514b6ad6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MPS Console |
| Version Model Number | 5001000 |
| Company DUNS | 041810693 |
| Company Name | QUEST MEDICAL INC |
| 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 | 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 | 1-800-627-0226 |
| custserv@questmedical.com | |
| Phone | 1-800-627-0226 |
| custserv@questmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20634624501007 [Primary] |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-10-12 |
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| 20634624530397 - MPS 3 Drug Pump Cover | 2023-04-03 |
| 20634624101153 - Q2 IV Administration Set | 2022-12-14 |
| 20634624101252 - Q2 IV Administration Set | 2022-12-14 |
| 20634624101306 - Q2 IV Administration Set | 2022-12-14 |
| 20634624601257 - Q2 IV Administration Set | 2022-12-14 |
| 20634624921096 - High-Flow 4-Way Stopcock | 2022-12-14 |
| 20634624921102 - High-Flow 4-Way Stopcock | 2022-12-14 |