BYD CARE FE2311

GUDID 00850022724176

BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level 3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags

BYD Precision Manufacture Co., Ltd.

Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit

• Primary Device ID: 00850022724176
• NIH Device Record Key: 9f1d211d-3939-4e15-bce8-4b35cbe1531f
• Commercial Distribution Discontinuation: 2050-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BYD CARE
• Version Model Number: FE2311
• Catalog Number: FE2311
• Company DUNS: 545255648
• Company Name: BYD Precision Manufacture Co., Ltd.
• 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: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com
• Phone: 1(800)2932886
• Email: byd.care@byd.com

Device Dimensions

• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch
• Area/Surface Area: 25.77 Square inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.
• Storage Environment Temperature: Between -20 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022724176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200923

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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [BYD CARE]

• 00860003624807: Single-use Face Mask Soft & Easy to Breath Use as Surgical Mask
• 00860003645154: N95 Health Care Particulate Respirator and Surgical Mask
• 00850022724169: BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili
• 00850022724176: BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammabili