Kosmos Power Pack (Refurbished)

GUDID 09353278000724

Kosmos Power Pack (Refurbished)

ECHONOUS, INC.

Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack

• Primary Device ID: 09353278000724
• NIH Device Record Key: f8cbac45-1669-461a-8644-da4137b589a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kosmos Power Pack (Refurbished)
• Version Model Number: R007640
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	09353278000724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212100

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2023-03-20
• Device Publish Date: 2023-03-10

Devices Manufactured by ECHONOUS, INC.

• 09353278000632 - Kosmos Power Pack: 2023-03-20 Kosmos Power Pack
• 09353278000724 - Kosmos Power Pack (Refurbished): 2023-03-20Kosmos Power Pack (Refurbished)
• 09353278000724 - Kosmos Power Pack (Refurbished): 2023-03-20 Kosmos Power Pack (Refurbished)
• 09353278000663 - EchoNous Samsung S8 Tablet with Software: 2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software
• 09353278000670 - EchoNous Samsung S8 Tablet with Software (Refurbished): 2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished)
• 09353278000717 - Kosmos OTS iOS Software Package: 2023-03-14 Kosmos OTS iOS Software Package
• 09353278000700 - Kosmos OTS Android Doppler Software Package: 2023-02-13 Kosmos OTS Android Doppler Software Package
• 09353278000687 - Kosmos OTS Android Linear: 2022-09-14 Kosmos on Android software application for ultrasound imaging
• 09353278000694 - Kosmos OTS Android Linear Color: 2022-09-14 Kosmos on Android software application for ultrasound imaging