SunTech CT40

GUDID 10840935108542

SUNTECH MEDICAL, INC.

Multiple physiological parameter spot-check system, clinical

• Primary Device ID: 10840935108542
• NIH Device Record Key: b7168b24-1e6f-487a-b2dd-96c507fb2e43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunTech CT40
• Version Model Number: 98-0811-00
• Company DUNS: 148191133
• Company Name: SUNTECH MEDICAL, 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: false
• 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: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com
• Phone: +1-919-654-2300
• Email: UDI_Mail@SunTechMed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935108542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160439

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-09
• Device Publish Date: 2019-05-15

Devices Manufactured by SUNTECH MEDICAL, INC.

• 10840935110477 - Skanray: 2024-06-28
• 10840935110217 - ProLife: 2023-06-19
• 10840935110224 - SunTech APC: 2023-06-19
• 10840935110231 - ProLife: 2023-06-19
• 10840935110248 - ProLife: 2023-06-19
• 10840935110255 - ProLife: 2023-06-19
• 10840935110262 - ProLife: 2023-06-19
• 10840935110279 - SunTech APC: 2023-06-19