Sure & Me

GUDID 26973069130002

Jiangmen Sure&Me Medical Product Co., Ltd.

Surgical/medical face mask, single-use

• Primary Device ID: 26973069130002
• NIH Device Record Key: 53835d37-5a72-49ef-97d8-58327ca73803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure & Me
• Version Model Number: MP002-5
• Company DUNS: 544326854
• Company Name: Jiangmen Sure&Me Medical 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973069130008 [Unit of Use]
GS1	16973069130005 [Primary]
GS1	26973069130002 [Package]; Contains: 16973069130005; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202577

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: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [Sure & Me]

• 26973069130019: MP002-6
• 26973069130002: MP002-5