Care

GUDID B754BFM0011

Blue 3 ply Medical Face Mask

GD CARE INC.

Surgical/medical face mask, single-use

• Primary Device ID: B754BFM0011
• NIH Device Record Key: dfd64a71-dd66-4bbc-9fa2-3aed7990cab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care
• Version Model Number: BFM-001
• Company DUNS: 080925610
• Company Name: GD CARE INC.
• Device Count: 1
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B754BFM001 [Primary]
HIBCC	B754BFM0011 [Package]; Contains: B754BFM001; Package: Inner [50 Units]; In Commercial Distribution
HIBCC	B754BFM0012 [Package]; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202191

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-06
• Device Publish Date: 2021-12-29

On-Brand Devices [Care]

• B754BFM0011: Blue 3 ply Medical Face Mask
• B754ON500251: ON Nitrile Powder Free Medical Gloves Size Extra Extra Large
• B754ON500201: ON Nitrile Powder Free Medical Gloves Size Extra Large
• B754ON500151: ON Nitrile Powder Free Medical Gloves Size Large
• B754ON500101: ON Nitrile Powder Free Medical Gloves Size Medium
• B754ON500051: ON Nitrile Powder Free Medical Gloves Size Small
• B754CS5201: Nitrile Powder Free Medical Gloves Size Extra Large
• B754CS5151: Nitrile Powder Free Medical Gloves Size Large
• B754CS5101: Nitrile Powder Free Medical Gloves Size Medium
• B754CS5051: Nitrile Powder Free Medical Gloves Size Small
• B754CS5001: Nitrile Powder Free Medical Gloves Size Extra Small
• B754CBK95201: Care 6 Mil 9 Inches Black Nitrile Exam Powder Free Gloves - X-Large
• B754CBK95151: 6 Mil 9 Inches Black Nitrile Exam Powder Free Gloves - Large
• B754CBK95101: 6 Mil 9 Inches Black Nitrile Exam Powder Free Gloves - Medium
• B754CBK95051: 6 Mil 9 Inches Black Nitrile Exam Powder Free Gloves - Small
• B754CBK125201: 6 Mil 12 Inches Black Nitrile Exam Powder Free Gloves - Extra Large
• B754CBK125151: 6 Mil 12 Inches Black Nitrile Exam Powder Free Gloves - Large
• B754CBK125101: 6 Mil 12 Inches Black Nitrile Exam Powder Free Gloves - Medium
• B754CBK125051: 6 Mil 12 Inches Black Nitrile Exam Powder Free Gloves - Small