AccessGUDID - DEVICE: VAPROX (00724995153106)

GUDID

Device Identifier (DI) Information

Brand Name: VAPROX
Version or Model: PB012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PB012
Company Name: STERIS CORPORATION

Primary DI Number: 00724995153106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828222781 *Terms of Use

Device Description: VAPROX HC Sterilant is 59 percent Hydrogen Peroxide used with V-PRO Low Temperature Sterilization Systems. The cup carries RFID tag. Net contents 4-29.6 mL per cup.

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):	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?
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
MLR	Sterilizer, chemical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172754	000
K182568	000
K190103	000
K190917	000
K222093	000
K233065	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: 050e050a-5edb-43e6-b9a2-bcec3f623f68
Public Version Date: May 15, 2024
Public Version Number: 7
DI Record Publish Date: August 23, 2018