CMO8 Adult PMP Oxygenator with Tubing Pack CME40009

GUDID 05060912587483

The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

CHALICE MEDICAL LIMITED

Extracorporeal membrane oxygenation system circuit

• Primary Device ID: 05060912587483
• NIH Device Record Key: 7c35cbad-ed9f-4dee-8abe-cf7957f73107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMO8 Adult PMP Oxygenator with Tubing Pack
• Version Model Number: CME40009
• Catalog Number: CME40009
• Company DUNS: 236289299
• Company Name: CHALICE MEDICAL LIMITED
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com
• Phone: +440190917077
• Email: enquiries@chalicemedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.
• Storage Environment Temperature: Between 5 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *to be stored in a dry, room temperature area and protected from direct solar or UV light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060491619810 [Previous]
GS1	05060912587483 [Primary]
GS1	15060912587480 [Package]; Package: [3 Units]; In Commercial Distribution

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [CMO8 Adult PMP Oxygenator with Tubing Pack]

• 15060491619817: The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation
• 05060912587483: The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation