FDA.reportPublic FDA data

G Dundas 14610 Passive Waste Gas Scavenger

Primary DI
00863735000314
Brand
G Dundas 14610 Passive Waste Gas Scavenger
Company
G DUNDAS CO INC
Model
14610
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K080039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080039000PASSIVE WASTE GAS SCAVENGER, MODEL 14600G. Dundas Co.,Inc.2008-04-14CBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863735000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863735000314008637350003148637350003140863735000314

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021817267
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863735000307G Dundas 1925 Active Waste Scavenger19252016-09-23
00863735000321DGSS147002016-09-23

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