etCO2 Respiratory Mechanics Pod

GUDID 04049098008167

DRAEGER MEDICAL SYSTEMS, INC.

Patient monitoring system module, multifunction

• Primary Device ID: 04049098008167
• NIH Device Record Key: 6dcd6b49-86c9-45ee-948f-00d9a41b4284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: etCO2 Respiratory Mechanics Pod
• Version Model Number: 5740704
• 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: true
• 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

Customer Support Contacts

• Phone: +18004372437
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098008167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954632

FDA Product Code

• BZK: Spirometer, Monitoring (W/Wo Alarm)

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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