KINGFA

GUDID 16973163400011

Guangdong KINGFA SCI.&TECH. Co., Ltd.

Surgical/medical face mask, single-use

• Primary Device ID: 16973163400011
• NIH Device Record Key: ef9825e0-3486-46b2-8879-d7733b1d29fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KINGFA
• Version Model Number: KF-B P05(L3)
• Company DUNS: 543265548
• Company Name: Guangdong KINGFA SCI.&TECH. Co., Ltd.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973163400014 [Unit of Use]
GS1	16973163400011 [Primary]
GS1	26973163400018 [Package]; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202139

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: 2020-12-30
• Device Publish Date: 2020-12-22

On-Brand Devices [KINGFA]

• 06973163400021: 1
• 06973163400007: 1
• 16973163400066: KF-B P05
• 16973163400011: KF-B P05(L3)
• 26973163400100: KF-A F02(N)
• 26975390735017: nitrile examination gloves small size
• 26975390734973: nitrile examination gloves small size