FDA.reportPublic FDA data

Amsco V-PRO

Primary DI
00724995151980
Brand
Amsco V-PRO
Company
Steris Mexico, S. de R.L. de C.V.
Model
1 Plus
Catalog number
VP2
Device description
The Amsco V-PRO 1 Plus Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLRSterilizer, chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083097000
K102330000
K102394000
K111810000
K112813000
K120632000
K131120000
K160433000
K162413000
K172319000
K190103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083097000AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2009-08-03MLR
K102330000AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2011-08-12MLR
K102394000AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2011-08-18MLR
K111810000AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITSSTERIS Corporation2011-09-02MLR
K112813000AMSCO V-PROSteris Corp2011-12-01MLR
K120632000AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2012-06-26MLR
K131120000AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2013-07-16MLR
K160433000V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation2016-07-06MLR
K162413000AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation2017-03-31MLR
K172319000AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation2018-01-18MLR
K190103000V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization SystemSTERIS Corporation2019-04-05MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995151980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995151980007249951519807249951519800724995151980

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide gas sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using hydrogen peroxide (H2O2) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It includes a treatment chamber where the devices to be sterilized are placed, usually after cleaning of gross debris, and a means to introduce the gas into the chamber; it is not intended to generate a gas plasma. 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
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
813116209
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995364168AMSCOAMSCO 700 Steam SterilizerEJ11202210012026-10-08
00724995364175AMSCOAMSCO 700 Steam SterilizerEJ11201400012026-10-08
00724995364182AMSCOAMSCO 700 Steam SterilizerEJ11202410012026-10-08
00724995364199AMSCOAMSCO 700 Steam SterilizerEJ11201410012026-10-08
00724995364205AMSCOAMSCO 700 Steam SterilizerEJ12201100012026-10-08
00724995364212AMSCOAMSCO 700 Steam SterilizerEJ12201400012026-10-08
00724995364229AMSCOAMSCO 700 Steam SterilizerEJ12202410012026-10-08
00724995364236AMSCOAMSCO 700 Steam SterilizerEJ12201410012026-10-08
00724995364243AMSCOAMSCO 700 Steam SterilizerEJ12213410012026-10-08
00724995364250AMSCOAMSCO 700 Steam SterilizerEJ13201100012026-10-08
00724995364267AMSCOAMSCO 700 Steam SterilizerEJ13201400012026-10-08
00724995364274AMSCOAMSCO 700 Steam SterilizerEJ13213400012026-10-08
00724995364281AMSCOAMSCO 700 Steam SterilizerEJ112022100112026-10-08
00724995364298AMSCOAMSCO 700 Steam SterilizerEJ112014000112026-10-08
00724995364304AMSCOAMSCO 700 Steam SterilizerEJ112024100112026-10-08
00724995364311AMSCOAMSCO 700 Steam SterilizerEJ112014100112026-10-08
00724995364328AMSCOAMSCO 700 Steam SterilizerEJ122011000112026-10-08
00724995364335AMSCOAMSCO 700 Steam SterilizerEJ122014000112026-10-08
00724995364342AMSCOAMSCO 700 Steam SterilizerEJ122024100112026-10-08
00724995364359AMSCOAMSCO 700 Steam SterilizerEJ122014100112026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
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00889024636583Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636613Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636675Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636682Trilogy®Zimmer, Inc.MLR2022-02-25
00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29
00889024569485Trilogy®Zimmer, Inc.MLR2019-04-10