FDA.reportPublic FDA data

FRU, GII Office Controller, Wall Mount

Primary DI
00813830028188
Brand
FRU, GII Office Controller, Wall Mount
Company
ACCUTRON, INC.
Model
26816-FRU
Catalog number
26816-FRU
Device description
FRU, GII Office Controller, Wall Mount
Published
2018-10-25
Public version status
New
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830028188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830028188008138300281888138300281880813830028188

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air/nitrous oxide breathing gas mixerAn independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00628101631819OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631826OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631833OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631871OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631888OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631918OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631925OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631932OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631949OhioOHIO MEDICAL, LLCBYX2026-03-23
00848530108632CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-03-19