MIMOSA

GUDID 00627987881806

MIMOSA Diagnostics Inc

Tissue saturation oximeter

• Primary Device ID: 00627987881806
• NIH Device Record Key: f53b3e5b-b21f-466c-a39f-2ae6ad233150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIMOSA
• Version Model Number: MIMOSA Pro
• Company DUNS: 203491998
• Company Name: MIMOSA Diagnostics Inc
• 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627987881806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190334

FDA Product Code

• MUD: Oximeter, Tissue Saturation

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: 2022-02-09
• Device Publish Date: 2022-02-01