Kosmos OTS iOS

GUDID 09353278000762

KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]

ECHONOUS, INC.

Ultrasound imaging system application software

• Primary Device ID: 09353278000762
• NIH Device Record Key: bcdd2976-41de-4c79-8b73-15811c4d96ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kosmos OTS iOS
• Version Model Number: P007944
• Company DUNS: 080481089
• Company Name: ECHONOUS, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353278000762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193518

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Kosmos OTS iOS ]

• 09353278000762: KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
• 09353278000823: Kosmos Application loaded on an iPad.