Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10194717117711
• Version / Model: AN01234
• Company Name: ROI CPS, LLC
• Labeler DUNS: 117174678
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-07
• Public Version: 1
• Public Version Date: 2023-08-15
• Public Version Status: New
• Public Device Record Key: b3fd9b61-0cb7-49be-b1b8-f9aa72d14ab8

Device Description

CODE CART DRAWER 3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35693	Cardiopulmonary resuscitation kit, single-use	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20194717117718	GS1		7	In Commercial Distribution
Primary	10194717117711	GS1