FDA.reportPublic FDA data

FRU Newport O2 Regulator

Primary DI
00813830020496
Brand
FRU Newport O2 Regulator
Company
ACCUTRON, INC.
Model
25746
Catalog number
25746
Published
2016-09-24
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
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830020496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830020496008138300204968138300204960813830020496

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

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
00850027043852Precision Medical Inc.Precision Medical, Inc.CAN2026-02-25
00819601025790Alcon Laboratories Inc.Airgas Therapeutics, LLCCAN2026-02-19
00848530108168RegulatorsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-02-02
10848530108127RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
10848530108158RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
00199972000177CuraplexBOUND TREE MEDICAL, LLCCAN2026-01-23
00851440007483Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CAN2025-12-13
00848530107765Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-11-24
16977645350528XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350535XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350542SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350559SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350566SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350573SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350580SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350597SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350603XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350610XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350627XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350634XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350641XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350658XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
10848530107410React Regulator ValveSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-09-17
08592346978812MediVital EGCE, s.r.o.CAN2025-08-08
16977645350184SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350276SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350207SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350214SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350382SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350399SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16