BYD CARE

Basic Information

• Brand Name: BYD CARE
• Primary DI: 00850022724190
• Version / Model: FE2311
• Catalog Number: FE2311
• Company Name: Global Healthcare Product Solutions, LLC
• Labeler DUNS: 080884832
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-07
• Public Version: 1
• Public Version Date: 2021-03-15
• Public Version Status: New
• Public Device Record Key: 6f556ca1-8c1b-462e-b40d-14338723d877
• Distribution End Date: 2021-03-07

Device Description

BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXX	Mask, Surgical	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61938	Surgical/examination garment kit	A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850022724190	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K200923	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	25.77	Square inch

Storage Conditions

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