FDA.reportPublic FDA data

Recessed Q/C Dual Outlet

Primary DI
00813830021684
Brand
Recessed Q/C Dual Outlet
Company
ACCUTRON, INC.
Model
34005
Catalog number
34005
Published
2023-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXHGauge, Gas Pressure, Cylinder/Pipeline
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXHGauge, Gas Pressure, Cylinder/PipelineAnesthesiology1
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830021684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830021684008138300216848138300216840813830021684

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas pipeline systemAn assembly of devices designed to supply compressed medical gases [e.g., oxygen (O2), nitrous oxide (N2O), medical air, surgical-grade air] from a central source to endpoints throughout a medical facility. The system typically consists of several gas supplies (bulk gas, bottled gas with air compressors), a pipework system that includes pressure regulators, pressure relief valves, zone valves, an alarm system with remote or local indicators, emergency backup devices for essential gases, and wall outlet/inlet terminal units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-483-7433regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
088302096
Device count
1
Premarket exempt
true
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
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
00813830021776Micro In-Line Dual DISS Outlet Kit, NS34013-3-NS34013-3-NS2016-09-27

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Primary DI, Brand, Company table
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B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
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10889483229279AirLife™SUNMED, LLCBYX2025-12-18
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