FDA.reportPublic FDA data

Amsco V-PRO

Primary DI
00724995151973
Brand
Amsco V-PRO
Company
Steris Mexico, S. de R.L. de C.V.
Model
1
Catalog number
VP1
Device description
The Amsco V-PRO 1 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
K062297000
K102330000
K102394000
K111810000
K112813000
K120632000
K131120000
K162413000
K172319000
K190103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062297000VHP 136 LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2007-10-04MLR
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
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
00724995151973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995151973007249951519737249951519730724995151973

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

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Primary DI, Brand, Company table
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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