FDA.reportPublic FDA data

Consolidated Sterilizer Systems

Primary DI
00860009513778
Brand
Consolidated Sterilizer Systems
Company
Consolidated Machine Corporation
Model
CSS 26BV-HC - Electric Steam
Device description
CSS 26BV-HC is a Steam Sterilizer designed for sterilization of moisture stable materials used in healthcare facilities. This model has an integral, electric steam generator. The 26BV-HC has a maximum capacity of 12 Double Wrapped Instrument Trays with a maximum weight of 25 pounds each or 16 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
00860009513778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009513778008600095137788600095137780860009513778

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
00860009513723Consolidated Sterilizer SystemsCSS 3AV-HC Loading Cart2023-03-13
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
00860009513785Consolidated Sterilizer SystemsCSS 26BV-HC Loading Cart2023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995364229AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
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00724995364243AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364250AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
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00724995364311AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364328AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
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00724995368562AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12