winner medical

GUDID 06941094021844

Winner Medical Co., Ltd.

Surgical/medical face mask, single-use

• Primary Device ID: 06941094021844
• NIH Device Record Key: 56ecd94b-641a-4099-be77-7133569909aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: winner medical
• Version Model Number: 604-006928
• Company DUNS: 530629351
• Company Name: Winner Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	06941094021844 [Package]; Contains: 06941094021851; Package: box [20 Units]; In Commercial Distribution
GS1	06941094021851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023755

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: 2020-07-02
• Device Publish Date: 2020-06-24

On-Brand Devices [winner medical]

• 26941094021077: 604-006807
• 16941094021070: 604-006807
• 06941094021844: 604-006928
• 26941094023835: 604-007355
• 16941094023609: 604-006881
• 26941094023224: 604-007330
• 16941094021186: 604-006873