Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 00326053118562
• Version / Model: ABGFLKT1CC25G-REG
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 134472476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-30
• Public Version: 1
• Public Version Date: 2022-07-08
• Public Version Status: New
• Public Device Record Key: ebffe173-e56b-49ea-b815-29c4a104fda0

Device Description

Full Kit Pulset, 1cc Syringe 25g x 5/8" Safety Tip 25u B (ABG)

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBT	Arterial Blood Sampling Kit	Anesthesiology	868.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31336	Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10326053118569	GS1		100	In Commercial Distribution
Primary	00326053118562	GS1