Com-Fit®

GUDID D687203402

Easy Breathe™ com-fit® mask Earloop Box of 40

Sultan Healthcare Inc

Surgical/medical face mask, single-use

• Primary Device ID: D687203402
• NIH Device Record Key: 7e9293f4-9379-470c-8a49-f68d3c70aa67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Com-Fit®
• Version Model Number: 20340
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 40
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)989-8825
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D687203400 [Unit of Use]
HIBCC	D687203401 [Primary]
HIBCC	D687203402 [Package]; Contains: D687203401; Package: Case [10 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-23

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