WXD Surgical Face Mask ( Non-Sterile)

GUDID 06945015300018

Wanxinda (Guangzhou)Technology Product Co.,Ltd.

Surgical/medical face mask, single-use

• Primary Device ID: 06945015300018
• NIH Device Record Key: 940a306e-755d-4c83-8713-0c0c037619e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WXD Surgical Face Mask ( Non-Sterile)
• Version Model Number: WXDKZ0006
• Company DUNS: 545308652
• Company Name: Wanxinda (Guangzhou)Technology Product Co.,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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945015300018 [Primary]
GS1	06945015300070 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202548

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: 2021-04-05
• Device Publish Date: 2021-03-28

On-Brand Devices [WXD Surgical Face Mask ( Non-Sterile)]

• 06945015300032: WXDKZ0001
• 06945015300018: WXDKZ0006