NBP-ONE NJ108

GUDID 10840935109211

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935109211
• NIH Device Record Key: 3f8ed1cc-2e99-4dc0-b77d-d4c28bbcca9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NBP-ONE
• Version Model Number: 98-1020-03
• Catalog Number: NJ108
• 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: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: 919-654-2300
• Email: UDI_Mail@suntechmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935109211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151520

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [NBP-ONE]

• 10840935109211: 98-1020-03
• 10840935109204: 91-0032-81
• 10840935109198: 91-0143-03