DEVICE: V-PRO (00724995152000)

Device Identifier (DI) Information

V-PRO
60
Not in Commercial Distribution
VP4
Steris Mexico, S. de R.L. de C.V.
00724995152000
GS1
March 25, 2024
1
813116209 *Terms of Use
The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized hydrogen peroxide Sterilizer intended for use in the terminal Sterilization of properly cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare Facilities.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

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Product Code Product Code Name
MLR Sterilizer, chemical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140498 000
K162413 000
K172319 000
K182568 000
K190917 000
K222849 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

38c3508f-2fc4-4954-b60e-7193ca4bb7a8
March 26, 2024
8
September 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
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Customer Contact

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+1(800)548-4873
xx@xx.xx
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