PRIMED

Basic Information

• Brand Name: PRIMED
• Primary DI: 00855135001893
• Version / Model: PM4-306
• Company Name: priMED Medical Products Inc
• Labeler DUNS: 253287569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-09-10
• Public Version: 2
• Public Version Date: 2025-09-26
• Public Version Status: Update
• Public Device Record Key: 459e33b3-0d1d-4a3a-9c77-6e82959551a6

Device Description

primaGARD120 Isolation Mask, Earloop, Blue

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66199	Surgical/medical face mask, non-antimicrobial, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	90855135001896	GS1
Primary	00855135001893	GS1
Package	10855135001890	GS1	Case	10	In Commercial Distribution

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry, and well ventilated space out of direct sunlight.