Exhaust Collection Bag

GUDID 20850008595022

Single exhaust collection bag in pouch

CHANNEL MEDSYSTEMS, INC.

Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system

• Primary Device ID: 20850008595022
• NIH Device Record Key: d8b2c460-d55a-4dfd-b004-47bba345dbb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exhaust Collection Bag
• Version Model Number: FGS-7005
• 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	00850008595028 [Primary]
GS1	20850008595022 [Package]; Contains: 00850008595028; Package: Box of 10 [10 Units]; In Commercial Distribution

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: false

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

On-Brand Devices [Exhaust Collection Bag]

• 20850008595022: Single exhaust collection bag in pouch
• 00850008595042: Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Devic