VAPROX

Basic Information

• Brand Name: VAPROX
• Primary DI: 00724995089160
• Version / Model: PB007
• Catalog Number: PB007
• Company Name: STERIS CORPORATION
• Labeler DUNS: 828222781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 9
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: 86779cd0-34ab-47a8-91f5-805cb774503b

Device Description

The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide and is used with V-PRO Low Temperature Sterilization Systems. The net contents are 113 mL per cup.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLR	Sterilizer, chemical	General Hospital	880.6860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995089167	GS1	Case	3	In Commercial Distribution
Primary	00724995089160	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062297	000
K083097	000
K102330	000
K102394	000
K111810	000
K112760	000
K112813	000
K120632	000
K131120	000
K140498	000
K160433	000
K172319	000
K182568	000
K190103	000
K190917	000
K222093	000
K233065	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep upright and away from open flame.
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 65 Percent (%) Relative Humidity