Luesay

GUDID 06973125150902

Medical Protective Mask

Guangdong Golden Leaves Technology Development Co., Ltd.

Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 06973125150902
• NIH Device Record Key: 46236845-e8de-4535-9785-ac0e51e9d440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luesay
• Version Model Number: 8862E
• Company DUNS: 554552994
• Company Name: Guangdong Golden Leaves Technology Development Co., Ltd.
• Device Count: 20
• 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: 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	06973125150902 [Primary]
GS1	16973125150909 [Unit of Use]
GS1	26973125150906 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223068

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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [Luesay]

• 06973125150889: Medical Protective Mask
• 06973125150865: Medical Protective Mask
• 06973125150902: Medical Protective Mask
• 06973125150896: Medical Protective Mask
• 06973125150872: Medical Protective Mask
• 06973125150858: Medical Protective Mask