Ear-Friendly Mask

GUDID 08800003025008

Ray Co., Ltd

Surgical/medical face mask, single-use

• Primary Device ID: 08800003025008
• NIH Device Record Key: 6a5b0110-e70c-454a-904f-a4950fcbab79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ear-Friendly Mask
• Version Model Number: Ear-Friendly Mask
• Company DUNS: 690324087
• Company Name: Ray 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	08800003025008 [Primary]
GS1	08800003025206 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211105

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: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [Ear-Friendly Mask]

• 18800003025005: Ear-Friendly Mask
• 08800003025008: Ear-Friendly Mask