Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10326053115339
• Version / Model: AN1041
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 945020902
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-10
• Public Version: 5
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 2fc6c444-e523-4863-8c69-83e4ccf8bceb
• Distribution End Date: 2020-08-26

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: MR Safe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OKE	Port Introducer Kit	General Hospital	880.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20326053115336	GS1		3	Not in Commercial Distribution	2019-05-24
Primary	10326053115339	GS1
Package	20326053116753	GS1		4	Not in Commercial Distribution	2020-08-26