Shield PFLEL8-1

GUDID H816PFLEL82

High-Efficiency Face Mask w/ Earloop

CERTOL INTERNATIONAL, LLC

Surgical/medical face mask, single-use

• Primary Device ID: H816PFLEL82
• NIH Device Record Key: 886ef26b-0054-42a6-befe-5b58f492b7f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shield
• Version Model Number: PFLEL8
• Catalog Number: PFLEL8-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, 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: 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
HIBCC	H816PFLEL80 [Unit of Use]
HIBCC	H816PFLEL81 [Primary]
HIBCC	H816PFLEL82 [Package]; Contains: H816PFLEL81; Package: Case Box [6 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Shield]

• H816PFLEL82: High-Efficiency Face Mask w/ Earloop
• H816PFL0082: High-Efficiency Face Mask with Headband