Health-Tec Earloop Masks 450-10021

GUDID D773450100211

Health-Tec Earloop Masks, Level 1, Pink

Dental Health Products Inc

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

• Primary Device ID: D773450100211
• NIH Device Record Key: 9057cd60-4e02-4977-9373-11c18f9cf567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec Earloop Masks
• Version Model Number: 450-10021
• Catalog Number: 450-10021
• Company DUNS: 623191194
• Company Name: Dental Health Products 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: true
• 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

Customer Support Contacts

• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773450100210 [Unit of Use]
HIBCC	D773450100211 [Primary]
HIBCC	D773450100212 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020474

FDA Product Code

• MSH: Respirator,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: 2017-01-18

On-Brand Devices [Health-Tec Earloop Masks]

• D773450100211: Health-Tec Earloop Masks, Level 1, Pink
• D773450100202: Health-Tec Earloop Masks, Level 1, Blue