FDA.reportPublic FDA data

V-PRO

Primary DI
00724995158354
Brand
V-PRO
Company
Steris Mexico, S. de R.L. de C.V.
Model
max 2
Catalog number
VP50002101
Device description
The V-PRO maX 2 Low Temperature Sterilization System is used in the terminal sterilization of properly prepared, cleaned, rinsed and dried medical devices utilizing VAPROX HC Sterilant.
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K172754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172754000V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation2018-02-09MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995158354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995158354007249951583547249951583540724995158354

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800066500306STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
00889024636118Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636132Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636170Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636187Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636224Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636231Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636255Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636279Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636286Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636309Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636323Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636330Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636378Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636385Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636408Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636415Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636439Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636453Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636460Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636477Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636507Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636545Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636583Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636613Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636675Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636682Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636699Trilogy®Zimmer, Inc.MLR2022-02-25
00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29