AccessGUDID - DEVICE: Amsco V-PRO (00724995151973)

GUDID

Device Identifier (DI) Information

Brand Name: Amsco V-PRO
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VP1
Company Name: Steris Mexico, S. de R.L. de C.V.

Primary DI Number: 00724995151973
Issuing Agency: GS1
Commercial Distribution End Date: March 25, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 813116209 *Terms of Use

Device Description: The Amsco V-PRO 1 Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.

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?
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 [?]
K062297	000
K102330	000
K102394	000
K111810	000
K112813	000
K120632	000
K131120	000
K162413	000
K172319	000
K190103	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ac3cabe-8c81-42a3-8e90-3a77886c882a
Public Version Date: March 26, 2024
Public Version Number: 6
DI Record Publish Date: September 14, 2016