Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator CME40004

GUDID 15060491614126

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

CHALICE MEDICAL LIMITED

Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit Extracorporeal membrane oxygenation system circuit

• Primary Device ID: 15060491614126
• NIH Device Record Key: 5ec173ca-873b-4257-9a10-15f37cd39656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator
• Version Model Number: CME40004
• Catalog Number: CME40004
• 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: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com
• Phone: +441909470777
• Email: enquiries@chalicemedical.com

Operating and Storage Conditions

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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	05060491614129 [Primary]
GS1	15060491614126 [Package]; Contains: 05060491614129; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201642

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: 2023-11-15
• Device Publish Date: 2023-11-07

Devices Manufactured by CHALICE MEDICAL LIMITED

• 15060491614126 - Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator: 2023-11-15The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
• 15060491614126 - Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator: 2023-11-15 The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulm
• 05060491617915 - Paragon Adult Maxi PMP Oxygenator: 2021-01-28 The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and