NBP-ONE NJ127

GUDID 10840935109204

SUNTECH MEDICAL, INC.

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• Primary Device ID: 10840935109204
• NIH Device Record Key: 2520b83c-fa5d-499e-98ec-23aaf3b8c2a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NBP-ONE
• Version Model Number: 91-0032-81
• Catalog Number: NJ127
• 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	10840935109204 [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