Demistifier

Basic Information

• Brand Name: Demistifier
• Primary DI: 00860013652302
• Version / Model: 2000A
• Company Name: Peace Medical Inc
• Labeler DUNS: 010906881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-12
• Public Version: 1
• Public Version Date: 2025-08-20
• Public Version Status: New
• Public Device Record Key: db63f300-f54a-4507-92de-9df873028e54

Device Description

Portable HEPA Air Filtration System

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBN	Apparatus, Gas-Scavenging	Anesthesiology	868.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34849	Anaesthesia workstation gas scavenger	A pneumatically-powered device that is a component of an anaesthesia workstation and connects between the expiratory valve or port of a breathing circuit and the extraction system enabling the waste anaesthetic, exhaled, or other trace gasses to be removed under controlled conditions from the work environment and channelled to the outside of the building. Filters or absorbers may be required to clean the removed gasses before discharging to the atmosphere. This device is also known as an anaesthetic gas scavenging system (AGSS).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013652302	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K902161	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in Dry Place