FDA.reportPublic FDA data

Elbow Mask With Pop-Off Valve

Primary DI
00813830023220
Brand
Elbow Mask With Pop-Off Valve
Company
ACCUTRON, INC.
Model
47075
Catalog number
47075
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
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813830023220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830023220008138300232208138300232200813830023220

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

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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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20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344042187HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
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07045432118186Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
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07045432119305Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
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07045432119770Pocket Mask, HC Yellow (EN)Laerdal Medical ASKGB2025-08-25
07045432119251Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119268Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119275Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119299Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119312Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119336Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
07045432119879Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29
07045432119947Pocket Mask O2, PB (EN)Laerdal Medical ASKGB2025-07-29
07045432120004Pocket Mask O2, SP Blue (EN)Laerdal Medical ASKGB2025-07-29
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00840117345263Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30