Lanhine

GUDID 06971513688150

Zhejiang Lanhine Medical Products Ltd.

Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use

• Primary Device ID: 06971513688150
• NIH Device Record Key: 29081357-7150-4ee4-9459-828a856ccc8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lanhine
• Version Model Number: 15604F
• Company DUNS: 543514472
• Company Name: Zhejiang Lanhine Medical Products Ltd.
• Device Count: 50
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch
• Length: 5.7 Inch
• Width: 3.7 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971513688150 [Primary]
GS1	06971513688181 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211827

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: 2023-02-20
• Device Publish Date: 2023-02-11

On-Brand Devices [Lanhine]

• 06971513689515: 15604F
• 06971513688150: 15604F
• 16971513688171: 15604F
• 16971513688164: 15604F
• 06971513688181: 15604F