FDA.reportPublic FDA data

Consolidated Sterilizer Systems

Primary DI
00860009513723
Brand
Consolidated Sterilizer Systems
Company
Consolidated Machine Corporation
Model
CSS 3AV-HC Loading Cart
Device description
The CSS 3AV-HC Loading Cart is a loading accessory for the CSS 3AV-HC steam sterilizer.The loading cart has a maximum capacity of 3 Double Wrapped Instrument Trays a maximum weight of 25 pounds each or 9 fabric packs.
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220736000Consolidated HC Steam SterilizerConsolidated Machine Corp.2022-08-01FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009513723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009513723008600095137238600095137230860009513723

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

Contacts#

Phone, Email table
PhoneEmail
617-782-7221PM@consteril.com

Regulatory Flags#

DUNS number
001020403
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009513709Consolidated Sterilizer SystemsCSS 3AV-HC - House Steam2023-03-13
00860009513716Consolidated Sterilizer SystemsCSS 3AV-HC - Electric Steam2023-03-13
00860009513730Consolidated Sterilizer SystemsCSS 26AV-HC - House Steam2023-03-13
00860009513747Consolidated Sterilizer SystemsCSS 26AV-HC - Electric Steam2023-03-13
00860009513754Consolidated Sterilizer SystemsCSS 26AV-HC Loading Cart2023-03-13
00860009513761Consolidated Sterilizer SystemsCSS 26BV-HC - House Steam2023-03-13
00860009513778Consolidated Sterilizer SystemsCSS 26BV-HC - Electric Steam2023-03-13
00860009513785Consolidated Sterilizer SystemsCSS 26BV-HC Loading Cart2023-03-13

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