Fluidproof MK1-11

GUDID D832MK1112

Earloop Mask, Black

PLASDENT CORPORATION

Surgical/medical respirator, antimicrobial

• Primary Device ID: D832MK1112
• NIH Device Record Key: 6a36b53e-12da-4022-b561-ebfe698de0ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluidproof
• Version Model Number: MK1-11
• Catalog Number: MK1-11
• Company DUNS: 190377184
• Company Name: PLASDENT CORPORATION
• Device Count: 50
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D832MK1110 [Unit of Use]
HIBCC	D832MK1111 [Primary]
HIBCC	D832MK1112 [Package]; Contains: D832MK1111; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133070

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: 2022-03-07
• Device Publish Date: 2022-02-25

On-Brand Devices [Fluidproof]

• D832MK16N2: Earloop Mask, Neon Pink
• D832MK1112: Earloop Mask, Black
• D832MK110N2: Earloop Mask, Neon Purple