CO2 Easy

GUDID 20709078621349

CO2 Easy

WESTMED, INC.

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• Primary Device ID: 20709078621349
• NIH Device Record Key: 9ce36d9b-baa3-4804-acca-a9597c6b2676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2 Easy
• Version Model Number: 562134
• Company DUNS: 092673953
• Company Name: WESTMED, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078621345 [Primary]
GS1	20709078621349 [Package]; Contains: 00709078621345; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072220

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

On-Brand Devices [CO2 Easy]

• 00709078621352: Pedi CO2 Easy Detector
• 20709078621349: CO2 Easy