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
00724995179168AMSCOAMSCO 600 Steam SterilizerEF11024322021-04-02
00724995179298AMSCOAMSCO 600 Steam SterilizerEF12023102021-04-02
00724995197414AMSCOAMSCO 600 Steam SterilizerEF1202442001022021-04-02
00724995223274AMSCOAMSCO 600 Steam SterilizerEF110232023-02-13
07350109400281NA15990-2215990222022-10-26
07350109400298NA15990-2315990232022-10-26
07350109400304NA15990-2415990242022-10-26
00724995196455AMSCOAMSCO 600 Steam SterilizerEF1102410001012021-09-27
00724995196462AMSCOAMSCO 600 Steam SterilizerEF1102310001012021-09-27
00724995196493AMSCOAMSCO 600 Steam SterilizerEF1102422001012021-09-27
00724995196509AMSCOAMSCO 600 Steam SterilizerEF1102322001012021-09-27
00724995196530AMSCOAMSCO 600 Steam SterilizerEF1102432001012021-09-27
00724995196547AMSCOAMSCO 600 Steam SterilizerEF1102332001012021-09-27
00724995196578AMSCOAMSCO 600 Steam SterilizerEF1102440001012021-09-27
00724995196585AMSCOAMSCO 600 Steam SterilizerEF1102340001012021-09-27
00724995196615AMSCOAMSCO 600 Steam SterilizerEF1102442001012021-09-27
00724995196622AMSCOAMSCO 600 Steam SterilizerEF1102342001012021-09-27
00724995196639AMSCOAMSCO 600 Steam SterilizerEF1201210001012021-09-27
00724995196646AMSCOAMSCO 600 Steam SterilizerEF1201110001012021-09-27
00724995196653AMSCOAMSCO 600 Steam SterilizerEF1202410001012021-09-27

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