SW Options (confi)

GUDID 04049098007078

DRAEGER MEDICAL SYSTEMS, INC.

Patient monitoring system central station monitor

• Primary Device ID: 04049098007078
• NIH Device Record Key: 34268de2-ec8f-439e-b2e1-7b9660e3cbdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SW Options (confi)
• Version Model Number: MS10950
• Company DUNS: 788289952
• Company Name: DRAEGER MEDICAL SYSTEMS, 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098007078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061379

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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