CARESCAPE SPO2

GUDID 00840682123921

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient monitoring system module, multifunction

• Primary Device ID: 00840682123921
• NIH Device Record Key: 57f94c09-4e57-4758-8ca4-70434a27ebe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESCAPE SPO2
• Version Model Number: MKS101
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682123921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200494

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [CARESCAPE SPO2]

• 00840682123976: MKS201
• 00840682123921: MKS101