Savvy Mask® Level 3 Surgical Face Mask

GUDID 10850025566138

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 head ties, ear loops or 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

Texas Medplast, LLC

Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 10850025566138
• NIH Device Record Key: 1602f426-f2dc-4229-8f09-42ead529369b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Savvy Mask® Level 3 Surgical Face Mask
• Version Model Number: SM01
• Company DUNS: 117718048
• Company Name: Texas Medplast, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025566131 [Primary]
GS1	10850025566138 [Package]; Contains: 00850025566131; Package: CASE [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213406

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-22

On-Brand Devices [Savvy Mask® Level 3 Surgical Face Mask]

• 10850025566138: The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks
• 10850025566169: The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks