Com-Fit®

GUDID D687203522

com-fit Plush™ Masks CFP-1 Earloop Box of 40

Sultan Healthcare Inc

Surgical/medical face mask, single-use

• Primary Device ID: D687203522
• NIH Device Record Key: aa20737e-9e39-4241-bcac-b463e9e1405e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Com-Fit®
• Version Model Number: 20352
• 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	D687203520 [Unit of Use]
HIBCC	D687203521 [Primary]
HIBCC	D687203522 [Package]; Contains: D687203521; 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

On-Brand Devices [Com-Fit®]

• D687203572: Com-Fit Plush™ Natural Fit Masks ASTM #3 Box of 40
• D687203562: Com-Fit Plush™ Natural Fit Masks ASTM #2 Box of 40
• D687203552: Com-Fit Plush™ Natural Fit Masks ASTM #1 Box of 40
• D687203542: com-fit Plush™ Masks CFP-3 Earloop Box of 40
• D687203532: com-fit Plush™ Masks CFP-2 Earloop Box of 40
• D687203522: com-fit Plush™ Masks CFP-1 Earloop Box of 40
• D687203502: Groovy Mask com-fit® mask Earloop Box of 40
• D687203462: Super Sensitive com-fit® mask Earloop Box of 50
• D687203442: Super Sensitive com-fit® mask Tie-On Box of 50
• D687203422: Easy Breathe™ com-fit® mask Tie-On Box of 40
• D687203402: Easy Breathe™ com-fit® mask Earloop Box of 40
• D687203362: Super High Filtration com-fit® mask Tie-On Box of 40
• D687203282: Super High Filtration with eyeshield com-fit® Earloop Box of 25
• D687203262: Super High Filtration com-fit® mask Earloop Box of 40
• D687203252: Fluid Resistant Procedural Pink com-fit® mask Box of 50
• D687203242: Fluid Resistant Procedural Blue com-fit® mask Box of 50