FDA.reportPublic FDA data

Demistifier

Primary DI
00860013652302
Brand
Demistifier
Company
Peace Medical Inc
Model
2000A
Device description
Portable HEPA Air Filtration System
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBNApparatus, Gas-Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBNApparatus, Gas-ScavengingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902161000DEMISTIFIER ISOLATION CHAMBERPeace Medical, Inc.1990-10-15CBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013652302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013652302008600136523028600136523020860013652302

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation gas scavengerA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in Dry Place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-973-672-2120info@peacemedical.com

Regulatory Flags#

DUNS number
010906881
Device count
1
Serial number
true
Contains natural rubber latex
true

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