AccessGUDID - DEVICE: 125-280 Solution™ for STERIZONE VP4 Sterilizer (00690455440102)

GUDID

Device Identifier (DI) Information

Brand Name: 125-280 Solution™ for STERIZONE VP4 Sterilizer
Version or Model: 44010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44010
Company Name: TSO3 Inc

Primary DI Number: 00690455440102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 256900895 *Terms of Use

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

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:	Yes
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?
44835	Hydrogen peroxide device sterilant	A 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.	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
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44f8331f-6173-47bc-b6ee-3d4c0c005e7b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2016