STERIZONE® VP4 Sterilizer

Primary DI
00690455440003
Brand
STERIZONE® VP4 Sterilizer
Company
TSO3 Inc
Model
44000-R
Catalog number
44000-R
Device description
The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00690455440003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690455440003006904554400036904554400030690455440003

GMDN Terms#

Term, Definition table
TermDefinition
Ozone/hydrogen peroxide sterilizerA mains electricity (AC-powered) device designed for terminal sterilization and/or inactivation of microorganisms from medical devices and related products using a combination of vaporized hydrogen peroxide (H2O2) and ozone gas as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available as a stand-alone (bulk) unit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity35 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius26 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius38 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
Serial number
true

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
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
00690455440102125-280 Solution™ for STERIZONE VP4 SterilizerTSO3 IncPJJ2016-09-14
00690455045604125-280 Solution™ for STERIZONE VP4 SterilizerTSO3 IncPJJ2016-09-14