TumEase

GUDID 00860002270210

Dot and Diamond Acupressure Bracelets

MUMEASE LLC

Acupressure wristband

• Primary Device ID: 00860002270210
• NIH Device Record Key: dce8255f-0d96-4df3-ac67-80b033e64ec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TumEase
• Version Model Number: B2
• Company DUNS: 101956090
• Company Name: MUMEASE LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002270210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193374

FDA Product Code

• MVV: Device, Acupressure

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: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [TumEase]

• 00860002270258: Diamond and Checkered Acupressure Bracelets
• 00860002270241: Painted and Checkered Acupressure Bracelets
• 00860002270234: Painted and Diamond Acupressure Bracelets
• 00860002270227: Dot and Painted Acupressure Bracelets
• 00860002270210: Dot and Diamond Acupressure Bracelets
• 00860002270203: Dot and Checkered Acupressure Bracelets