FDA.reportPublic FDA data

FRU Newport tank Restraint Strap Replacement Kit

Primary DI
00813830020489
Brand
FRU Newport tank Restraint Strap Replacement Kit
Company
ACCUTRON, INC.
Model
25681
Catalog number
25681
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00813830020489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830020489008138300204898138300204890813830020489

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957513Create BiotechCREATE BIOTECH CO., LTD.BXH2026-07-21
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