CARESCAPE CENTRAL STATION 5867474-03

GUDID 00195278343383

MAI800 MEDICAL DEVICE

Ge Medical Systems Information Technologies, Inc.

Centralized patient monitor

• Primary Device ID: 00195278343383
• NIH Device Record Key: f0168c1e-6126-46d8-99a8-997e89920dab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESCAPE CENTRAL STATION
• Version Model Number: MAI800
• Catalog Number: 5867474-03
• Company DUNS: 118935631
• Company Name: Ge Medical Systems Information Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278343383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162012

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-19
• Device Publish Date: 2026-02-11

On-Brand Devices [CARESCAPE CENTRAL STATION]

• 00840682109666: V2 Integrated MAI 700
• 00840682109604: V2 Standard MAS 700
• 00195278343512: MAS800 MEDICAL DEVICE
• 00195278343383: MAI800 MEDICAL DEVICE