FDA.reportPublic FDA data

Axess CapnographyAdapters

Primary DI
00813830027464
Brand
Axess CapnographyAdapters
Company
ACCUTRON, INC.
Model
53055
Catalog number
53055
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00813830027464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830027464008138300274648138300274640813830027464

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088302096
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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00810339030315SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031121SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339030322SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031138SAFE DENTBGSS Company Inc.KHA2024-05-15
D974BSIBL011BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL021BritedentBright Supply, Inc.KHA2023-09-18
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
04260635790431AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790523AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790547AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
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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
16975316480031BESTARWUHAN BESTAR INDUSTRY CO.,LTDKHA2022-12-19
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