MAQUET CARDIOHELP 70107.1881
GUDID 04058863112176
CARDIOHELP Emergency Drive
Maquet Cardiopulmonary AG
Cardiopulmonary bypass system, roller type| Primary Device ID | 04058863112176 |
| NIH Device Record Key | fa63ea37-066f-45a1-8573-15e105929714 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAQUET CARDIOHELP |
| Version Model Number | CARDIOHELP Emergency Drive (w/o holder) |
| Catalog Number | 70107.1881 |
| Company DUNS | 316153865 |
| Company Name | Maquet Cardiopulmonary AG |
| 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 |
Customer Support Contacts
| Phone | +49072229320 |
| info.cp@maquet.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04058863112176 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133598
FDA Product Code
| DTQ | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-26 |
| Device Publish Date | 2018-09-25 |
Devices Manufactured by Maquet Cardiopulmonary AG
| 04037691075068 - VBT Venous Bubble Trap | 2023-06-02 Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap VBT 160 is designed to remove gross air in the ve |
| 04037691032528 - NA | 2023-06-02 |
| 04037691576640 - Quadrox-iD | 2022-12-13 |
| 04037691588285 - HLS Set | 2022-12-13 |
| 04037691741130 - NA | 2022-12-08 |
| 04037691741543 - NA | 2022-12-08 |
| 04037691773513 - NA | 2022-12-08 |
| 04037691009025 - NA | 2022-12-06 |
Trademark Results [MAQUET CARDIOHELP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAQUET CARDIOHELP 79068911 3870249 Live/Registered |
Maquet Cardiopulmonary GmbH 2009-05-07 |
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