Cerene Cryotherapy Device

GUDID 00850008595035

CHANNEL MEDSYSTEMS, INC.

Hand-held cryosurgical system

• Primary Device ID: 00850008595035
• NIH Device Record Key: 17af5448-366c-4141-a382-3d959ce6bd5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerene Cryotherapy Device
• Version Model Number: FGS-7000
• Company DUNS: 963415513
• Company Name: CHANNEL MEDSYSTEMS, 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: false
• 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

Customer Support Contacts

• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com
• Phone: 510-338-9301
• Email: support@channelmedsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008595035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180032

FDA Product Code

• MNB: Device, Thermal Ablation, Endometrial

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: 2020-08-31
• Device Publish Date: 2020-08-21

Devices Manufactured by CHANNEL MEDSYSTEMS, INC.

• 00850008595042 - Exhaust Collection Bag: 2023-04-14 Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device
• 20850008595022 - Exhaust Collection Bag: 2020-08-31 Single exhaust collection bag in pouch
• 00850008595035 - Cerene Cryotherapy Device: 2020-08-31
• 00850008595035 - Cerene Cryotherapy Device: 2020-08-31