Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10326053117340
• Version / Model: AN1084
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 134472476
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-18
• Public Version: 5
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: 159c49a1-b760-4705-b64c-f90408856c19
• Distribution End Date: 2022-11-03

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
OGD	Custom Anesthesia Tray	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20326053117347	GS1		5	Not in Commercial Distribution	2022-11-03
Primary	10326053117340	GS1