Starling CMMST5S

GUDID 07290013030290

A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.

CHEETAH MEDICAL (ISRAEL) LTD

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 07290013030290
• NIH Device Record Key: 941c33ec-280a-4dd3-aa61-9b69bf5c2e88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Starling
• Version Model Number: CMMST5S
• Catalog Number: CMMST5S
• Company DUNS: 533390019
• Company Name: CHEETAH MEDICAL (ISRAEL) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 360 828-8685
• Email: starling_rma@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1 800 422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)422-9837
• Email: medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013030290 [Primary]
GS1	72900130302906 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103166

FDA Product Code

• DSB: Plethysmograph, Impedance

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: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [Starling]

• 07290013030290: A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
• 07290013030269: A portable, non-invasive cardiac output (CO) monitoring device.
• 77290013030046: The Starling sensors are accessories to the Starling Monitor which provides continuous non-invas
• 07290013030047: The Starling sensors are accessories to the Starling Monitor which provides continuous non-invas