Henry Schein 5700723

GUDID 20304040063433

MaxiGard Air Earloop Mask White

HENRY SCHEIN, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20304040063433
• NIH Device Record Key: 664ef74e-d5d1-4c16-84c3-a4909836a2c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein
• Version Model Number: 5700723
• Catalog Number: 5700723
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040063439 [Unit of Use]
GS1	10304040063436 [Primary]
GS1	20304040063433 [Package]; Contains: 10304040063436; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-05-21

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• 10304040054250: Essentials LED Curing Light, Black
• 10304040054243: Essentials LED Curing Light
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• 00304040039519: CENTRIFUGE MIRCROHEMATOCR
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• 10304040039479: Bur Block Plastic 8 Hole
• 10304040039462: Bur Block Plastic 14 Hole
• 10304040039455: Bur Block Plastic 8 Hole
• 10304040039448: Bur Block Plastic 8 Hole
• 10304040039431: Bur Block Plastic 14 Hole
• 10304040039424: Bur Block Plastic 14 Hole
• 10304040039417: Bur Block Magnetic 8 Hole
• 10304040039400: Bur Block Magnetic 14 Hole
• 10304040039394: Bur Block Magnetic 8 Hole
• 10304040039387: Bur Block Magnetic 14 Hole
• 10304040039370: Bur Block Magnetic 8 Hole
• 10304040039363: Bur Block Magnetic 14 Hole
• 00304040037089: Calcium Hydroxide Temporary Root Filling Material
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• 10304040026547: Sharps Container, 8 Gallon Red
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