CARESCAPE

GUDID 00840682109833

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 00840682109833
• NIH Device Record Key: 084bd710-ed6c-47eb-b5ef-505c1e8f1946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESCAPE
• Version Model Number: Central Station v1 upgrade
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• 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: 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

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682109833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133882

FDA Product Code

• NHP: Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-24

On-Brand Devices [CARESCAPE]

• 00840682109833: Central Station v1 upgrade
• 00840682109826: Central Station v1
• 00840682109383: T14 Transmitter
• 00840682109260: Telemetry Server V4
• 00840682108775: Telemetry Server v4 upgrade
• 00840682103930: 19 inch Display D19KT
• 00840682103091: V100