Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10194717102304
• Version / Model: UR00858B
• Company Name: ROI CPS, LLC
• Labeler DUNS: 117174678
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-28
• Public Version: 1
• Public Version Date: 2019-11-05
• Public Version Status: New
• Public Device Record Key: 2331d4fb-52ee-4dc7-a0e5-0934f905c57f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPA	Bladder Irrigation Kit	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10406	Bladder irrigation kit	A collection of sterile devices designed for the infusion of fluids used to flush and evacuate the bladder of urine and other particulate matter. It typically includes tubing, connectors, a syringe, a roller clamp and other items used to flush the bladder. It may also be indicated for use in such procedures as a cystoscopy or a transurethral resection (TUR) as a means of continuous bladder irrigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20194717102301	GS1		10	In Commercial Distribution
Primary	10194717102304	GS1