FDA.reportPublic FDA data

Dynamic Gas Scavenging System

Primary DI
00863573000408
Brand
Dynamic Gas Scavenging System
Company
Anesthetic Gas Reclamation, LLC
Model
DGSS - 2
Device description
"Waste anesthetic gas (WAG) scavenging interface for anesthesia delivery machines which replaces the active or passive scavenging interface with a more efficient ""closed"" unit. Made in USA"
Published
2023-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K193646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193646000Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.2020-12-04CBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863573000408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863573000408008635730004088635730004080863573000408

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
023784203
Device count
1
Serial number
true

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