FDA.reportPublic FDA data

All American

Primary DI
00089149019418
Brand
All American
Company
WISCONSIN ALUMINUM FOUNDRY COMPANY, INC.
Model
1941X
Device description
Table top non-electric steam sterilizer
Published
2021-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00089149019418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089149019418000891490194180891490194180089149019418

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
006076855
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089149019159All American1915X2021-05-05
00089149019258All American1925X2021-05-05
00089149501203All American50X1202021-05-05
00089149502408All American50X2402021-05-05
00089149751202All American75X1202021-05-05
00089149752407All American75X2402021-05-05

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06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
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