FDA.reportPublic FDA data

Prevention

Primary DI
10068460505197
Brand
Prevention
Company
Virox Technologies Inc
Model
HLD8 High Level Disinfectant
Catalog number
25505
Device description
A reusable high level disinfectant solution designed to be used with heat sensitive medical devices and instruments, for which heat sterilization is not suitable.
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEDSterilant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091022000MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANTSTERIS Corporation2010-04-12MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10068460505197PackageGS14In Commercial Distribution
00068460505190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1006846050519710068460505197
00068460505190000684605051900684605051900068460505190

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfectantA substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep in original container

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003877578bgivehchi@virox.com
8003877578lchum@virox.com

Regulatory Flags#

DUNS number
255343022
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10068460505135PreventionHLD8 Solution Test StripsAHPHLD82017-08-01
00068460505190PreventionHLD8 High Level Disinfectant255052017-08-01
10068460506170Optim 33 Tb Wipes (CAN)Stubby2022-05-26
00068460506494Optim 1 (US)8oz2022-05-26
00068460506555Optim 1 (US)1G2022-05-26
10068460506538Optim 1 Wipes (US)10x102022-05-26
00068460506166Optim 1 (CAN)3.78L2022-05-26
00068460506197Optim 33 Tb (CAN)1L2022-05-26
00068460506227Optim 33 Tb (CAN)3.78L Aloe2022-05-26
00068460506258Optim 33 Tb (CAN)1L Aloe2022-05-26
00068460506289Optim 33 Tb (CAN)3.78L2022-05-26
00068460506326Optim Blue (CAN)3.78L2022-05-26
00068460506364Optim 33 Tb (US)32oz2022-05-26
00068460506388Optim 33 Tb (US)1G2022-05-26
00068460506418Optim 1 (US)32oz2022-05-26
07640185070349Optim Blue (EU)3.78L2022-05-26
07640185070738Optim 1 (EU)3.78L2022-05-26
10068460506200Optim 33 Tb (CAN)6x7 Aloe2022-05-26
10068460506279Optim 1 Wipes (CAN)6x72022-05-26
10068460506293Optim 33 Tb Wipes (CAN)6x72022-05-26

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