FDA.reportPublic FDA data

Optim 1 (US)

Primary DI
00068460506333
Brand
Optim 1 (US)
Company
Virox Technologies Inc
Model
8oz
Published
2022-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00068460506333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00068460506333000684605063330684605063330068460506333

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses); it may contain surfactants/cleaning agents or 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 to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
255343022
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344029317MEDLINEMEDLINE INDUSTRIES, INC.LRJ2026-04-27
04039239075462Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
04039239075479Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.LRJ2025-12-15
10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
08859335502220POSE HEALTH CARE LIMITED POSE HEALTH CARE LIMITEDLRJ2025-09-05
00615375013458CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00615375013472CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
00850065253244LIVE TULA Alcohol Pads 1.0 (100pcs/box)TULA HEALTH, INC.LRJ2025-03-18
06976301910710YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910727YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910734YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910741YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910758YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910765YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910772YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910789YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
10197344017690MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28