FDA.reportPublic FDA data

125-280 Solution™ for STERIZONE VP4 Sterilizer

Primary DI
00690455045604
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
Rx
false
OTC
true
Sterile
false
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 Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
256900895
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
00690455438109STERIZONE® CI+ Chemical indicator43810-143810-12016-09-14
00690455440102125-280 Solution™ for STERIZONE VP4 Sterilizer44010440102016-09-14
00690455426021STERIZONE® BI+ Self-contained Biological Indicator42602-142602-12016-09-14
00690455440003 STERIZONE® VP4 Sterilizer44000-R44000-R2016-09-14
00690455440201 STERIZONE® VP4 Test Pack Kit44020440202016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690455440102125-280 Solution™ for STERIZONE VP4 SterilizerTSO3 IncPJJ2016-09-14
00690455440003 STERIZONE® VP4 SterilizerTSO3 IncPJJ2016-09-14