ETCO2 Sensor

GUDID 06970706360668

Respironics Compatible, Mainstream, 3.0M

Orantech Inc.

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• Primary Device ID: 06970706360668
• NIH Device Record Key: c92509fb-7530-4c0a-b905-478246a1606b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETCO2 Sensor
• Version Model Number: CTM-RP01
• Company DUNS: 544423370
• Company Name: Orantech 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970706360668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171828

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2021-01-04
• Device Publish Date: 2020-12-25

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