FDA.report

N2O-O2 2+2 Manifold

Primary DI
00813830021899
Brand
N2O-O2 2+2 Manifold
Company
ACCUTRON, INC.
Model
34063
Catalog number
34063
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BXHGauge, Gas Pressure, Cylinder/Pipeline

Product Code Classifications

CodeDeviceSpecialtyClass
BXHGauge, Gas Pressure, Cylinder/PipelineAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813830021899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830021899008138300218998138300218990813830021899

GMDN Terms

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

Regulatory Flags

DUNS number
088302096
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00813830027099Nitrogen Add On KitACCUTRON, INC.BXH2023-10-05
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00813830021721Recessed QC Outlet VacuumACCUTRON, INC.BXH2023-09-22
00813830021844Surface Q/C Triple OutletACCUTRON, INC.BXH2023-09-22
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00813830022049Surface Q/C O2 OutletACCUTRON, INC.BXH2023-09-22
00813830022056Surface Imperial N2 OutletACCUTRON, INC.BXH2023-09-22
00813830022063Surface Schrader N2 OutletACCUTRON, INC.BXH2023-09-22
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00813830024029Riser, FRU, O2, Cylinder RoomACCUTRON, INC.BXH2023-09-22
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00813830024432Pre-Install Digi-Flo A & C Desk MountACCUTRON, INC.BXH2023-09-22
00813830024449Pre-Install Digi-Flo B & D Wall MountACCUTRON, INC.BXH2023-09-22
00813830024753Zone Valve, Digi-FloACCUTRON, INC.BXH2023-09-22
00813830025255Zone Valve Adapter Box, Digi-FloACCUTRON, INC.BXH2023-09-22
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00813830021684Recessed Q/C Dual OutletACCUTRON, INC.BXH2023-09-14