FDA.reportPublic FDA data

Prevention

Primary DI
10068460505135
Brand
Prevention
Company
Virox Technologies Inc
Model
HLD8 Solution Test Strips
Catalog number
AHPHLD8
Device description
A high level disinfectant concentration monitor dedicated for use with Prevention HLD8 High Level Disinfectant.
Published
2017-08-01
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
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10068460505135PrimaryGS10
00068460505138Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1006846050513510068460505135
00068460505138000684605051380684605051380068460505138

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature6 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep Dry and Keep away from direct light

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
255343022
Device count
60
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10068460506309Optim 33 Tb Wipes (US)6x72022-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
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00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05