SunTech Medical

GUDID 10840935108825

SUNTECH MEDICAL, INC.

Multiple physiological parameter spot-check system, clinical

• Primary Device ID: 10840935108825
• NIH Device Record Key: e248d6cf-f3de-4ac6-a7f4-08ebf8cd428c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunTech Medical
• Version Model Number: 91-0028-16
• 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: true
• 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	10840935108825 [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: 2019-08-14

On-Brand Devices [SunTech Medical]

• 10840935108825: 91-0028-16
• 10840935108733: 91-0028-69