Lumax LMGRF-7.0-80-MPA
GUDID 00827002476318
Lumax Guiding Catheter Guiding Coaxial Design
COOK INCORPORATED
Vascular guide-catheter, single-use| Primary Device ID | 00827002476318 |
| NIH Device Record Key | 476685b0-12df-4b06-b793-88e2430f7a6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumax |
| Version Model Number | G47631 |
| Catalog Number | LMGRF-7.0-80-MPA |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| 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 | true |
| Expiration Date | true |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002476318 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191163
FDA Product Code
| DQY | Catheter, percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-29 |
| Device Publish Date | 2020-12-21 |
Devices Manufactured by COOK INCORPORATED
| 00827002352674 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352681 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352698 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352704 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352711 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 10827002346014 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002346939 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002347110 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
Trademark Results [Lumax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUMAX 98341795 not registered Live/Pending |
SECOND CONTINENTAL IP, LLC 2024-01-04 |
 LUMAX 90229743 not registered Live/Pending |
VITRO, S.A.B. DE C.V. 2020-10-01 |
 LUMAX 88178722 not registered Dead/Abandoned |
Ji, Maxwell 2018-11-01 |
 LUMAX 86814649 4992810 Live/Registered |
Lumax LLC 2015-11-10 |
 LUMAX 78933342 3242322 Live/Registered |
Monobind, Inc. 2006-07-19 |
 LUMAX 78532414 not registered Dead/Abandoned |
InKine Pharmaceutical Company, Inc. 2004-12-14 |
 LUMAX 78210594 not registered Dead/Abandoned |
Folia Tec Bohm GmbH & Co. Vertriebs KG 2003-02-04 |
 LUMAX 76280179 2687341 Dead/Cancelled |
Worldwide Welding, Inc. 2001-07-02 |
 LUMAX 76146904 2769639 Dead/Cancelled |
Zeneca Limited 2000-10-13 |
 LUMAX 76085588 2772069 Live/Registered |
SYNGENTA LIMITED 2000-07-07 |
 LUMAX 74413983 1971615 Live/Registered |
COOK MEDICAL TECHNOLOGIES LLC 1993-07-19 |
 LUMAX 73012546 1016307 Dead/Expired |
CHADWICK-HELMUTH COMPANY, INC. 1974-02-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.