FDA.reportPublic FDA data

RFS Scavenging Circuit I

Primary DI
00813830021448
Brand
RFS Scavenging Circuit I
Company
ACCUTRON, INC.
Model
33008
Catalog number
33008
Published
2016-09-24
Public version status
Update
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
K033503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033503000RFS VACUUM GAUGE SCAVENGING CIRCUITAccutron, Inc.2004-03-12CBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830027877Direct MarkingGS10
00813830021448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830027877008138300278778138300278770813830027877
00813830021448008138300214488138300214480813830021448

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air/nitrous oxide breathing gas mixerAn independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088302096
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90813830028822Oxygen Connector, MQC x O2 DISS, Universal33969339692019-11-06
00813830020236FRU, Cartridge Body N2O24107241072025-06-30
00810085200130Ultra PC% Oral Surgery Package H36800-OS36800-OS2025-05-14
00813830021721Recessed QC Outlet Vacuum34011340112023-09-22
00813830021844Surface Q/C Triple Outlet34060340602023-09-22
00813830022032Surface Q/C Dual Outlet34076340762023-09-22
00813830022049Surface Q/C O2 Outlet34077340772023-09-22
00813830022056Surface Imperial N2 Outlet34078-I34078-I2023-09-22
00813830022063Surface Schrader N2 Outlet34078-S34078-S2023-09-22
00813830022070Surface Q/C Vacuum Outlet34079340792023-09-22
00813830021677Recessed Q/C Triple Outlet34004340042023-09-14
00813830021684Recessed Q/C Dual Outlet34005340052023-09-14
00813830021691Recessed Q/C O2 Outlet34009340092023-09-14
00813830021660Floor Q/C Dual Outlet34003340032016-09-27
00813830021707Recessed Imperial Nitrogen Outlet34010-I34010-I2016-09-28
00813830021714Recessed Schrader Q/C Outlet Nitrogen34010-S34010-S2016-09-28
00813830021738Micro In-Line Triple DISS Outlet Kit34012-334012-32016-09-28
00813830021745Micro In-Line Triple DISS Outlet Kit, NS34012-3-NS34012-3-NS2016-09-28
00813830021752Micro Outlet, Dual, DISS34013340132016-09-28
00813830021769Micro In-Line Dual DISS Outlet Kit34013-334013-32016-09-27

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Primary DI, Brand, Company table
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14026704929440RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
00816711020424NITRONOX SCAVENGERPARKER-HANNIFIN CORPORATIONCBN2025-09-24
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00816711024224SCAVENGER, EAVS, MIDASPARKER-HANNIFIN CORPORATIONCBN2025-02-21
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10858545007032SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
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14026704916648HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
14026704916655HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
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24026704916652HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
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00813830027327FRU, Axess To Accuvac AdaptorACCUTRON, INC.CBN2023-10-02
00813830027433Axess 90 Deg Outspout ConnectorACCUTRON, INC.CBN2023-10-02
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