M.BLUE FX820T
GUDID 04041906504557
M.BLUE 0 SYS W/CONTROL RESERVOIR
Aesculap AG
Ventriculo-peritoneal/atrial shunt| Primary Device ID | 04041906504557 |
| NIH Device Record Key | 4b00c828-04de-4051-9354-6943cf313666 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M.BLUE |
| Version Model Number | FX820T |
| Catalog Number | FX820T |
| Company DUNS | 315018218 |
| Company Name | Aesculap 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04041906504557 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192266
FDA Product Code
| JXG | Shunt, central nervous system and components |
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 | 2020-03-12 |
| Device Publish Date | 2020-03-04 |
On-Brand Devices [M.BLUE]
| 04041906505004 | M.BLUE CHECKMATE |
| 04041906504786 | M.BLUE 15 SYS W/PED.BURRHOLE RESERVOIR |
| 04041906504779 | M.BLUE 10 SYS W/PED.BURRHOLE RESERVOIR |
| 04041906504762 | M.BLUE 5 SYS W/PED.BURRHOLE RESERVOIR |
| 04041906504755 | M.BLUE 0 SYS W/PED.BURRHOLE RESERVOIR |
| 04041906504748 | M.BLUE 15 SYS W/SPRUNG RESERVOIR |
| 04041906504731 | M.BLUE 10 SYS W/SPRUNG RESERVOIR |
| 04041906504724 | M.BLUE 5 SYS W/SPRUNG RESERVOIR |
| 04041906504717 | M.BLUE 0 SYS W/SPRUNG RESERVOIR |
| 04041906504700 | M.BLUE 15 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504694 | M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504687 | M.BLUE 5 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504670 | M.BLUE 0 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504663 | M.BLUE 15 SYS W/SPRUNG RESERVOIR |
| 04041906504656 | M.BLUE 10 SYS W/SPRUNG RESERVOIR |
| 04041906504649 | M.BLUE 5 SYS W/SPRUNG RESERVOIR |
| 04041906504632 | M.BLUE 0 SYS W/SPRUNG RESERVOIR |
| 04041906504625 | M.BLUE 15 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504618 | M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504601 | M.BLUE 5 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504595 | M.BLUE 0 SYS W/PED.SPRUNG RESERVOIR |
| 04041906504588 | M.BLUE 15 SYS W/CONTROL RESERVOIR |
| 04041906504571 | M.BLUE 10 SYS W/CONTROL RESERVOIR |
| 04041906504564 | M.BLUE 5 SYS W/CONTROL RESERVOIR |
| 04041906504557 | M.BLUE 0 SYS W/CONTROL RESERVOIR |
| 04041906504540 | M.BLUE 15 SYS W/PED.CONTROL RESERVOIR |
| 04041906504533 | M.BLUE 10 SYS W/PED.CONTROL RESERVOIR |
| 04041906504526 | M.BLUE 5 SYS W/PED.CONTROL RESERVOIR |
| 04041906504519 | M.BLUE 0 SYS W/PED.CONTROL RESERVOIR |
| 04041906504502 | M.BLUE 15 SHUNT SYSTEM |
| 04041906504496 | M.BLUE 10 SHUNT SYSTEM |
| 04041906504489 | M.BLUE 5 SHUNT SYSTEM |
| 04041906504472 | M.BLUE 0 SHUNT SYSTEM |
| 04041906504465 | M.BLUE 15 VALVE W/PERITONEAL CATHETER |
| 04041906504458 | M.BLUE 10 VALVE W/PERITONEAL CATHETER |
| 04041906504441 | M.BLUE 5 VALVE W/PERITONEAL CATHETER |
| 04041906504434 | M.BLUE 0 VALVE W/PERITONEAL CATHETER |
| 04041906504427 | M.BLUE 15 VALVE |
| 04041906504410 | M.BLUE 10 VALVE |
| 04041906504403 | M.BLUE 5 VALVE |
| 04041906504397 | M.BLUE 0 VALVE |
Trademark Results [M.BLUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M.BLUE 87910118 not registered Live/Pending |
Christoph Miethke GmbH & Co. KG 2018-05-07 |
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