M.BLUE FX826T

GUDID 04041906504601

M.BLUE 5 SYS W/PED.SPRUNG RESERVOIR

Aesculap AG

Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 04041906504601
• NIH Device Record Key: ce02dbfd-db17-4e1e-b6ad-beddc225f9c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M.BLUE
• Version Model Number: FX826T
• Catalog Number: FX826T
• 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

• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041906504601 [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