ProGear

Basic Information

• Brand Name: ProGear
• Primary DI: 00852212003689
• Version / Model: RP88021
• Company Name: PRESTIGE AMERITECH, LTD.
• Labeler DUNS: 199692794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-10-14
• Public Version: 1
• Public Version Date: 2022-10-24
• Public Version Status: New
• Public Device Record Key: 9e4af25a-6b90-437c-b38e-cb4dfc1c7459

Device Description

N95 Surgical Mask Respirator with Comfort Strip, Regluar

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSH	Respirator, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64962	Half-face respirator body	A form-shaped respiratory mask (filters not included) intended to be placed over the nose and mouth of a person to permit normal breathing while preventing transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) to and from the wearer (i.e., upon inhalation and exhalation) when used with an appropriate filter(s) [not included]. It is constructed from pliable synthetic polymer materials designed to create an airtight seal against the user’s face, and typically includes ties/head straps. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80852212003685	GS1
Primary	00852212003689	GS1
Package	10852212003686	GS1		6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]