FDA.reportPublic FDA data

125-280 Solution™ for STERIZONE VP4 Sterilizer

Primary DI
00690455440102
Brand
125-280 Solution™ for STERIZONE VP4 Sterilizer
Company
TSO3 Inc
Model
44010
Catalog number
44010
Device description
The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
Published
2016-09-14
Public version status
Update
Distribution status
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
PJJTwo Or More Sterilant Sterilizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJJTwo Or More Sterilant SterilizerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153392000STERIZONE VP4 SterilizerTs03, Inc.2016-03-24PJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690455045604PackageGS14In Commercial Distribution
00690455440102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690455045604006904550456046904550456040690455045604
00690455440102006904554401026904554401020690455440102

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
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-866-715-0003info@tso3.com

Regulatory Flags#

DUNS number
256900895
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690455438109STERIZONE® CI+ Chemical indicator43810-143810-12016-09-14
00690455426021STERIZONE® BI+ Self-contained Biological Indicator42602-142602-12016-09-14
00690455440003 STERIZONE® VP4 Sterilizer44000-R44000-R2016-09-14
00690455045604125-280 Solution™ for STERIZONE VP4 Sterilizer44010440102016-09-14
00690455440201 STERIZONE® VP4 Test Pack Kit44020440202016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690455440003 STERIZONE® VP4 SterilizerTSO3 IncPJJ2016-09-14
00690455045604125-280 Solution™ for STERIZONE VP4 SterilizerTSO3 IncPJJ2016-09-14