FDA.reportPublic FDA data

FRU, Large Y Connector

Primary DI
00813830020038
Brand
FRU, Large Y Connector
Company
ACCUTRON, INC.
Model
21245
Catalog number
21245
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
KHAMask, Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHAMask, ScavengingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830020038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830020038008138300200388138300200380813830020038

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
false
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
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFFPARKER-HANNIFIN CORPORATIONKHA2026-02-23
00810339030322SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031138SAFE DENTBGSS Company Inc.KHA2024-05-15
00813830027464Axess CapnographyAdaptersACCUTRON, INC.KHA2023-09-22
D974BSIBL012BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL022BritedentBright Supply, Inc.KHA2023-09-18
D1243I50NE0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
D1243I50TC0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
04260635790448AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790479AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790486AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790530AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790554AirTechiquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790578AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790585AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790592AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790608AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
06933192201112Hakuna MatataFUJIAN BBC INCKHA2022-12-07
00816711020769Matrx Scavenger Large Nasal InhalerPARKER-HANNIFIN CORPORATIONKHA2022-12-06
04260635790103AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790158AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790493AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790714AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
00816711020974HOOD ASSY,ADULT,ONE LINERPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711020981HOOD ASSY,PEDO,ONE LINERPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711020998DISPOSABLE LINER, ADULT, BAGPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021001DISP LINER,ADULT,BAG,CITRUSPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021018DISPOSABLE LINER, ADULT, BOXPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021025DISP LINER,ADULT,BOX,CITRUSPARKER-HANNIFIN CORPORATIONKHA2022-11-15
00816711021032DISPOSABLE LINER, PEDO, BAGPARKER-HANNIFIN CORPORATIONKHA2022-11-15