989803105661

GUDID 00884838011908

Philips Medizin Systeme Böblingen GmbH

Electrode conductive medium

• Primary Device ID: 00884838011908
• NIH Device Record Key: 9876282d-df64-44b7-a7fb-dc61d4188e6c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803105661
• Catalog Number: 989803105661
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838011908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992674

FDA Product Code

• GWQ: Full-montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-12-13

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838124066 - MR Patient Care Portal Remote Display # 5000: 2025-06-12 MR Patient Care Portal 5000
• 00884838111363 - MR Patient Care Expression Model MR400 MRI Patient Monitoring System: 2025-06-10 Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smar
• 00884838111431 - MR Patient Care Wireless ECG 3.0 Module (Networks 1-5): 2025-06-10 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 1-5).
• 00884838111448 - MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5): 2025-06-10 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5).
• 00884838111455 - MR Patient Care Wireless SpO2 3.0 Module (Networks 6-10): 2025-06-10 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10).
• 00884838111462 - MR Patient Care Wireless ECG 3.0 Module (Networks 6-10): 2025-06-10 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10).
• 00884838111370 - MR Patient Care SpO2 Sensor: 2025-06-09 Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories
• 00884838111479 - MR Patient Care Temperature Sensor (Esophageal / Rectal / Axillary, Direct Mode): 2025-06-09 Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophog