Shield PFL008-1

GUDID H816MPFL0082

High-Efficiency Face Mask

MicroCare, LLC

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

• Primary Device ID: H816MPFL0082
• NIH Device Record Key: 47850919-b356-4226-8db8-b74a731b8100
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shield
• Version Model Number: PFL008
• Catalog Number: PFL008-1
• Company DUNS: 118518186
• Company Name: MicroCare, LLC
• 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	H816MPFL0080 [Unit of Use]
HIBCC	H816MPFL0081 [Primary]
HIBCC	H816MPFL0082 [Package]; Contains: H816MPFL0081; Package: Case Box [6 Units]; In Commercial Distribution
HIBCC	H816PFL0081 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890128

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: 2022-11-03
• Device Publish Date: 2022-10-26

Devices Manufactured by MicroCare, LLC

• H816GVUS1280 - Good Vibrations: 2024-08-29 Good Vibrations Gallon
• H816GVUS550 - Good Vibrations: 2024-08-29 Good Vibrations 55 Gallon Drum
• H816GVUSU240 - Good Vibrations: 2024-08-29 Good Vibrations Unit Dose
• H816VGVUS1280 - SpecClean Ultrasonic Cleaner Solution: 2024-08-29 SpecClean Ultrasonic Cleaner Solution Gallon
• H816SMQEZ22 - Spec Clean Endoscope Sponge: 2023-09-07 Enzymatic Presaturated Endoscopic Cleaning Sponge
• H816MBB0312H2 - ProBarrier: 2022-11-03 Environmental Surface Barrier, 3 x 12 instrument/equipment drape, chair sox
• H816MBB0528X2 - ProBarrier: 2022-11-03 Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox
• H816MBB2930C2 - ProBarrier: 2022-11-03 Environmental surface barrier, 29" x 30" Instrument/equipment drape chair sox