Vapor Line Reusable Process Challenge Device

Basic Information

• Brand Name: Vapor Line Reusable Process Challenge Device
• Primary DI: 30818087010994
• Version / Model: 26906900
• Catalog Number: 26906900
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Labeler DUNS: 001483130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-16
• Public Version: 1
• Public Version Date: 2023-06-26
• Public Version Status: New
• Public Device Record Key: 1190a20d-b4dd-4497-b2e6-c4a6528870e7

Device Description

Vapor Line Reusable Process Challenge Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30818087010994	GS1

Premarket Submissions

Submission Number	Supplement Number
K031152	000