M.BLUE PLUS FX891T

GUDID 04041906504977

M.BLUE PLUS COMPASS

Aesculap AG

Cerebrospinal fluid shunt valve programmer

• Primary Device ID: 04041906504977
• NIH Device Record Key: 9f782963-084b-44e0-b72b-f2430f87d0d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M.BLUE PLUS
• Version Model Number: FX891T
• Catalog Number: FX891T
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041906504977 [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: true
• Device Is Sterile: false

[04041906504977]

Moist Heat or Steam Sterilization

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 PLUS]

• 04041906504991: M.BLUE PLUS ADJUSTMENT ASSISTANT
• 04041906504984: M.BLUE PLUS ADJUSTMENT RING
• 04041906504977: M.BLUE PLUS COMPASS
• 04041906504960: M.BLUE PLUS INSTRUMENTS SET
• 04041906504885: M.BLUE PLUS SYS W/PED.BURRHOLE RESERVOIR
• 04041906504878: M.BLUE PLUS SYS W/SPRUNG RESERVOIR
• 04041906504861: M.BLUE PLUS SYS W/PED.SPRUNG RESERVOIR
• 04041906504854: M.BLUE PLUS SYS W/SPRUNG RESERVOIR
• 04041906504847: M.BLUE PLUS SYS W/PED.SPRUNG RESERVOIR
• 04041906504830: M.BLUE PLUS SYS W/CONTROL RESERVOIR
• 04041906504823: M.BLUE PLUS SYS W/PED.CONTROL RESERVOIR
• 04041906504816: M.BLUE PLUS SHUNT SYSTEM
• 04041906504809: M.BLUE PLUS VALVE W/PERITONEAL CATHETER
• 04041906504793: M.BLUE PLUS VALVE