Filac

GUDID 10840935106098

SUNTECH MEDICAL, INC.

Multiple physiological parameter spot-check system, clinical

• Primary Device ID: 10840935106098
• NIH Device Record Key: bd48f03c-6ee1-4744-a451-d905bb7db80d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filac
• Version Model Number: 45-0006-01
• 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: false
• 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	10840935106098 [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: 5
• Public Version Date: 2020-09-09
• Device Publish Date: 2016-09-12

On-Brand Devices [Filac]

• 10840935106586: 52-0009-01
• 10840935106579: 52-0009-00
• 10840935106104: 45-0006-00
• 10840935106098: 45-0006-01