Exhaust Collection Bag

GUDID 00850008595042

Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device

CHANNEL MEDSYSTEMS, INC.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00850008595042
• NIH Device Record Key: c80d6745-a773-4ffc-ba44-eb8a6c636029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exhaust Collection Bag
• Version Model Number: FGS-7015
• 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: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com
• Phone: +1-510-338-9301
• Email: support@cerene.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008595042 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-14
• Device Publish Date: 2023-04-06

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