MIMOSA

GUDID 00627987881806

MIMOSA Diagnostics Inc

Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter Tissue saturation oximeter 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