FDA.reportPublic FDA data

VAPROX

Primary DI
00724995089511
Brand
VAPROX
Company
STERIS CORPORATION
Model
PB028
Catalog number
PB028
Device description
The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide that is used with V-PRO Low Temperature Sterilization Systems. The net contents are 29.6 mL per cup.
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K083097000
K102330000
K102394000
K111810000
K112760000
K112813000
K120632000
K131120000
K140498000
K160433000
K162413000
K172319000
K172754000
K182568000
K190103000
K190917000
K222093000
K223476000
K233065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062297000VHP 136 LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2007-10-04MLR
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
K112760000AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2011-11-22MLR
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
K140498000V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2014-07-24MLR
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
K172754000V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation2018-02-09MLR
K182568000V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation2019-01-03MLR
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
K190917000V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization SystemsSTERIS Corporation2019-05-09MLR
K222093000V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization SystemSteris2022-09-09MLR
K223476000V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation2023-08-07MLR
K233065000V-PRO maX 2 Low Temperature Sterilization SystemSteris2023-10-20MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995089518PackageGS14Not in Commercial Distribution
00724995089511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499508951810724995089518
00724995089511007249950895117249950895110724995089511

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide device sterilantA gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep upright, dry, away from sunlight, and away from combustible material or open flame.
Storage Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
828222781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

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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00889024636231Trilogy®Zimmer, Inc.MLR2022-02-25
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00889024636460Trilogy®Zimmer, Inc.MLR2022-02-25
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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
00889024636705Trilogy®Zimmer, Inc.MLR2022-02-25