FDA.reportPublic FDA data

VAPROX

Primary DI
00724995153106
Brand
VAPROX
Company
STERIS CORPORATION
Model
PB012
Catalog number
PB012
Device description
VAPROX HC Sterilant is 59 percent Hydrogen Peroxide used with V-PRO Low Temperature Sterilization Systems. The cup carries RFID tag. Net contents 4-29.6 mL per cup.
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K172754000
K182568000
K190103000
K190917000
K222093000
K233065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
K233065000V-PRO maX 2 Low Temperature Sterilization SystemSteris2023-10-20MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995153101PackageGS14In Commercial Distribution
00724995153106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499515310150724995153101
00724995153106007249951531067249951531060724995153106

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
10885403096372V. MuellerOP26-001OP260012018-09-07
10885403096389V. MuellerOP26-002OP260022018-09-07
10885403096396V. MuellerOP26-003OP260032018-09-07
10885403096402V. MuellerOP27OP272018-09-07
10885403096426V. MuellerOP50OP502018-09-07
10885403096310V. MuellerOP10OP102018-09-07
10885403096327V. MuellerOP20OP202018-09-07
10885403096341V. MuellerOP24OP242018-09-07
10885403096365V. MuellerOP26OP262018-09-07
10885403096419V. MuellerOP30OP302018-09-07
10885403096433V. MuellerOP60OP602018-09-07
10885403096440V. MuellerOP70OP702018-09-07
10885403096457V. MuellerOP80OP802018-09-07
10885403096471V. MuellerOP112OP1122018-09-07
10885403096488V. MuellerOP113OP1132018-09-07
10885403096495V. MuellerOP120OP1202018-09-07
10885403096518V. MuellerOP160OP1602018-09-07
10885403096686V. MuellerOP330OP3302018-09-07
10885403132377V. MuellerSU3147SU31472018-09-18
10885403132384V. MuellerSU3148SU31482018-09-18

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
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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