FDA.reportPublic FDA data

AG Neovo

Primary DI
04710739590012
Brand
AG Neovo
Company
ASSOCIATED INDUSTRIES CHINA, INC.
Model
Louie P-M10TR
Device description
Sterilizer, Steam
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710739590012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710739590012047107395900124710739590012

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656068681
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710739590197AG NeovoREVOLUTION R-55102021-12-17
04710739590203AG NeovoREVOLUTION R-55002021-12-17
04710739590210AG NeovoREVOLUTION R-40102021-12-17
04710739590227AG NeovoREVOLUTION R-40002021-12-17
04710739590234AG NeovoREVOLUTION R-40052021-12-17
04710739590241AG NeovoREVOLUTION R-20102021-12-17
04710739590258AG NeovoREVOLUTION R-20002021-12-17
04710739590265AG NeovoREVOLUTION R-20052021-12-17
04710739590272AG NeovoREVOLUTION R-11052021-12-17
04710739590289AG NeovoREVOLUTION R-11042021-12-17
04710739590180AG NeovoAG neovo Dental Portable Dental Equipment PDE seri2021-11-12
04710739590111AG NeovoREVOLUTION R-6800B22020-12-31
04710739590128AG NeovoREVOLUTION R-6100S2020-12-31
04710739590135AG NeovoREVOLUTION R-6110DPS2020-12-31
04710739590142AG NeovoREVOLUTION R-6510WH2020-12-31
04710739590159AG NeovoREVOLUTION R-6110WH2020-12-31
04710739590166AG NeovoREVOLUTION R-6110N2020-12-31
04710739590173AG NeovoREVOLUTION R-6100N2020-12-31
04710739590029AG NeovoREVOLUTION R-6100K2020-06-30
04710739590036AG NeovoREVOLUTION R-6110K2020-06-30

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