Exhaust Collection Bag

Basic Information

• Brand Name: Exhaust Collection Bag
• Primary DI: 00850008595028
• Version / Model: FGS-7005
• Company Name: CHANNEL MEDSYSTEMS, INC.
• Labeler DUNS: 963415513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 1
• Public Version Date: 2020-08-31
• Public Version Status: New
• Public Device Record Key: d8b2c460-d55a-4dfd-b004-47bba345dbb1

Device Description

Single exhaust collection bag in pouch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNB	Device, Thermal Ablation, Endometrial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60507	Hand-held cryosurgical system	A hand-held assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin, subcutaneous, and/or mucosal tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It typically includes a single-use or reusable handpiece with disposable application tip and cryogen cartridge (e.g., N2O cartridge), whereby the cryogen is delivered through the handpiece to the tip which is applied to tissues. It can be used for dedicated applications or across clinical specialties (e.g., general surgery, dermatology, neurology, orthopaedics, gynaecology).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850008595022	GS1	Box of 10	10	In Commercial Distribution
Primary	00850008595028	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P180032	001