Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10326053121460
• Version / Model: A3ISOGXLNS-REG
• Catalog Number: A3ISOGXLNS-REG
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 134472476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-02-13
• Public Version: 1
• Public Version Date: 2024-02-21
• Public Version Status: New
• Public Device Record Key: c8d4b6df-330e-45dd-9b66-68c91fd6cd45

Device Description

Gown Isolation AAMI 3 Blue Cuff, XL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35492	Isolation gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20326053121467	GS1		8	In Commercial Distribution
Primary	10326053121460	GS1
Unit of Use	00326053121463	GS1

Premarket Submissions

Submission Number	Supplement Number
K212504	000