AccessGUDID - DEVICE: STERIZONE® VP4 Sterilizer (00690455440003)

GUDID

Device Identifier (DI) Information

Brand Name: STERIZONE® VP4 Sterilizer
Version or Model: 44000-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44000-R
Company Name: TSO3 Inc

Primary DI Number: 00690455440003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 256900895 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56749	Ozone/hydrogen peroxide sterilizer	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJJ	Two Or More Sterilant Sterilizer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153392	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 20 and 26 Degrees Celsius
Storage Environment Temperature: between 0 and 38 Degrees Celsius
Handling Environment Humidity: between 35 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d389528-7028-443b-a04f-2129d3efbf99
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2016