AccessGUDID - DEVICE: V-PRO (00724995158354)

GUDID

Device Identifier (DI) Information

Brand Name: V-PRO
Version or Model: max 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VP50002101
Company Name: Steris Mexico, S. de R.L. de C.V.

Primary DI Number: 00724995158354
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 813116209 *Terms of Use

Device Description: The V-PRO maX 2 Low Temperature Sterilization System is used in the terminal sterilization of properly prepared, cleaned, rinsed and dried medical devices utilizing VAPROX HC Sterilant.

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):	Yes
Over the Counter (OTC):	No
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?
40567	Hydrogen peroxide gas sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using hydrogen peroxide (H2O2) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It includes a treatment chamber where the devices to be sterilized are placed, usually after cleaning of gross debris, and a means to introduce the gas into the chamber; it is not intended to generate a gas plasma. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLR	Sterilizer, chemical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b031f7f0-ca2f-44d2-90d7-60bac6382703
Public Version Date: April 09, 2024
Public Version Number: 7
DI Record Publish Date: August 23, 2018