Starling SV CMMST5

GUDID 07290013030030

A portable, non-invasive cardiac output (CO) monitoring device

CHEETAH MEDICAL (ISRAEL) LTD

Impedance cardiograph

• Primary Device ID: 07290013030030
• NIH Device Record Key: c4430769-87c1-4b76-8944-caf45476dff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Starling SV
• Version Model Number: CMMST5
• Catalog Number: CMMST5
• 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: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• Phone: 999-999-9999
• Email: xx@xx.xx
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013030030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083093
• 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: 2021-04-15
• Device Publish Date: 2021-04-07

Devices Manufactured by CHEETAH MEDICAL (ISRAEL) LTD

• 07290013030047 - Starling: 2024-01-11 The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output
• 77290013030046 - Starling: 2023-12-20 The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output
• 07290013030269 - Starling: 2022-08-22 A portable, non-invasive cardiac output (CO) monitoring device.
• 07290013030290 - Starling: 2022-08-22 A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
• 07290013030030 - Starling SV: 2021-04-15A portable, non-invasive cardiac output (CO) monitoring device
• 07290013030030 - Starling SV: 2021-04-15 A portable, non-invasive cardiac output (CO) monitoring device
• 72900130302906 - Starling Monitor with SpO2 Module: 2021-04-15 A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module