BYD CARE DF1122

GUDID 00860003645154

N95 Health Care Particulate Respirator and Surgical Mask

BYD Precision Manufacture Co., Ltd.

Surgical/examination garment kit

• Primary Device ID: 00860003645154
• NIH Device Record Key: d018be8a-1c0f-4a9c-aa12-be52272cbab4
• Commercial Distribution Discontinuation: 2029-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BYD CARE
• Version Model Number: DF1122
• Catalog Number: DF1122
• Company DUNS: 545255648
• Company Name: BYD Precision Manufacture Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Dimensions

• Circumference: 16.5 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *DO NOT use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003645154 [Primary]

FDA Product Code

• MSH: Respirator, 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: 2020-04-14
• Device Publish Date: 2020-04-06

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