CO2 Easy

GUDID 00709078621352

Pedi CO2 Easy Detector

WESTMED, INC.

Exhaled-gas oesophageal intubation detector, adult

• Primary Device ID: 00709078621352
• NIH Device Record Key: 8f2c5e38-7ab1-460a-afb2-a781fe7f7c55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2 Easy
• Version Model Number: 562135
• 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	00709078621352 [Primary]
GS1	20709078621356 [Package]; 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