Fitgrow

GUDID 06974323931010

Hubei Yiya Protective Equipment Co., Ltd.

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

• Primary Device ID: 06974323931010
• NIH Device Record Key: 07610900-1ad7-4294-8e69-1ae3382817bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fitgrow
• Version Model Number: 17.5cm x 9.5cm YA-101
• Company DUNS: 712354938
• Company Name: Hubei Yiya Protective Equipment Co., Ltd.
• Device Count: 1
• 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: false
• 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	06974323931010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211899

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: 2022-12-09
• Device Publish Date: 2022-12-01