Regardo™

Basic Information

• Brand Name: Regardo™
• Primary DI: 10194717106852
• Version / Model: LD00044O
• Company Name: ROI CPS, LLC
• Labeler DUNS: 117174678
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 3
• Public Version Date: 2021-05-07
• Public Version Status: Update
• Public Device Record Key: 75f46594-ff0b-4136-8502-0670de188dfb
• Distribution End Date: 2021-05-07

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
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34988	Birthing/delivery kit	A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20194717106859	GS1		3	Not in Commercial Distribution	2021-05-07
Primary	10194717106852	GS1