Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 20326053105887
• Version / Model: 335543REG
• Catalog Number: 335543REG
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 134472476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-05-26
• Public Version: 1
• Public Version Date: 2023-06-05
• Public Version Status: New
• Public Device Record Key: 6d7c11a7-6e93-45ad-b559-e2540a470704

Device Description

Wash-Checks-50

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
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
Package	10326053105880	GS1		5	In Commercial Distribution
Primary	20326053105887	GS1
Unit of Use	00326053105883	GS1

Premarket Submissions

Submission Number	Supplement Number
K982188	000