Savvy Mask® Level 3 Surgical Face Mask

Basic Information

• Brand Name: Savvy Mask® Level 3 Surgical Face Mask
• Primary DI: 00850025566162
• Version / Model: SM03
• Company Name: Texas Medplast, LLC
• Labeler DUNS: 117718048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-23
• Public Version: 1
• Public Version Date: 2022-07-01
• Public Version Status: New
• Public Device Record Key: 24cb3184-cda5-483f-83fd-c5c9b5198ac1

Device Description

The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear bands to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex

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
Package	10850025566169	GS1	CASE	40	Not in Commercial Distribution	2022-06-24
Primary	00850025566162	GS1

Premarket Submissions

Submission Number	Supplement Number
K213406	000