FDA.reportPublic FDA data

4 Cylinder Portable (w/out Flowmeter)

Primary DI
00813830023053
Brand
4 Cylinder Portable (w/out Flowmeter)
Company
ACCUTRON, INC.
Model
44000
Catalog number
44000
Published
2016-09-28
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

Product Codes#

Code, Name table
CodeName
BXHGauge, Gas Pressure, Cylinder/Pipeline

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830023053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830023053008138300230538138300230530813830023053

GMDN Terms#

Term, Definition table
TermDefinition
Gas cylinder holderA device designed to hold and secure a single medical gas cylinder of compressed medical gas which is to be used in medical treatment/therapy. The usual gases are, [e.g., oxygen (O2), air, or nitrous oxide (N2O)]. It is used to secure the cylinder both during transport and typically whilst the gas is being used. The device is typically constructed of metal and may be mounted to a medical device service rail system, a bed under transport, or other medical devices requiring medical gas to be present. It is configured to meet the size of the cylinder, typically those of small dimensions.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813830020236FRU, Cartridge Body N2O24107241072025-06-30
00810085200130Ultra PC% Oral Surgery Package H36800-OS36800-OS2025-05-14
00813830028171WAGD Chemetron x 1/2" MNPT34976349762023-11-20
00813830021066FRU, Vacuum Connector With Barbs27324273242023-10-05
00813830022094Accutron Vacuum Male Connector34081340812023-10-05
00813830026856FRU, Axess Vacuum Gauge26699-FRU26699-FRU2023-10-05
00813830026924FRU, Valve, Pressure Relief, Digi-Flo27427-FRU27427-FRU2023-10-05
00813830026979FRU, Gauge Newport O223589-FRU23589-FRU2023-10-05
00813830027006FRU, O2 Hose, 2 Cyl.27172-FRU27172-FRU2023-10-05
00813830027013FRU, N2O Hose, 2 Cyl.27173-FRU27173-FRU2023-10-05
00813830027099Nitrogen Add On Kit48022480222023-10-05
00813830027372FRU, Accuvalve Assembly26786-FRU26786-FRU2023-10-05
00813830027839FRU, 4 Cylinder Remote Vacuum Kit28326-FRU28326-FRU2023-10-05
00813830028843FRU, Display Assy Digi-Flo Zone Valve28651-FRU28651-FRU2023-10-05
00813830027181FRU, Axess Scavenging Control, In-Line28530-FRU28530-FRU2023-10-02
00813830027327FRU, Axess To Accuvac Adaptor28559-FRU28559-FRU2023-10-02
00813830027433Axess 90 Deg Outspout Connector28417-FRU28417-FRU2023-10-02
00813830021721Recessed QC Outlet Vacuum34011340112023-09-22
00813830021844Surface Q/C Triple Outlet34060340602023-09-22
00813830022032Surface Q/C Dual Outlet34076340762023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813830027099Nitrogen Add On KitACCUTRON, INC.BXH2023-10-05
00813830027372FRU, Accuvalve AssemblyACCUTRON, INC.BXH2023-10-05
00813830028843FRU, Display Assy Digi-Flo Zone ValveACCUTRON, INC.BXH2023-10-05
00813830021721Recessed QC Outlet VacuumACCUTRON, INC.BXH2023-09-22
00813830021844Surface Q/C Triple OutletACCUTRON, INC.BXH2023-09-22
00813830022032Surface Q/C Dual OutletACCUTRON, INC.BXH2023-09-22
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
00813830022070Surface Q/C Vacuum OutletACCUTRON, INC.BXH2023-09-22
00813830024029Riser, FRU, O2, Cylinder RoomACCUTRON, INC.BXH2023-09-22
00813830024036Riser, FRU, N2O, Cylinder RoomACCUTRON, INC.BXH2023-09-22
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
00813830026962Zone Valve Adapter Box, Digi-Flo, NCACCUTRON, INC.BXH2023-09-22
00813830027334Digi-Flo N2O & O2 Brazed RisersACCUTRON, INC.BXH2023-09-22
00813830024791Digi-Flo Pkg. D, w Security Wall AlarmACCUTRON, INC.BXH2023-09-21
00813830024814Digi-Flo Pkg D, w Sec. Wall Alarm -NPACCUTRON, INC.BXH2023-09-21
008138300248452nd Alarm Panel, Digi-Flo, WallACCUTRON, INC.BXH2023-09-21
008138300248522nd Alarm, Digi-Flo, Wall, w SecurityACCUTRON, INC.BXH2023-09-21
00813830024982Digi-Flo Pkg C, w Sec. Desk AlarmACCUTRON, INC.BXH2023-09-21
00813830025187Digi-Flo Pkg C, w Sec. Desk Alarm -NPACCUTRON, INC.BXH2023-09-21
00813830025309Porter Manifold Adapter KitACCUTRON, INC.BXH2023-09-21
00813830025316Belmed Manifold Adapter KitACCUTRON, INC.BXH2023-09-21
00813830025323Accutron Manifold Adapter KitACCUTRON, INC.BXH2023-09-21
00813830020168FRU, Primary Check Valve O2ACCUTRON, INC.BXH2023-09-14
00813830021677Recessed Q/C Triple OutletACCUTRON, INC.BXH2023-09-14
00813830021684Recessed Q/C Dual OutletACCUTRON, INC.BXH2023-09-14