Norav NBP-ONE-K-00-01

GUDID 10840935108702

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935108702
• NIH Device Record Key: 22a3e0ff-4a9b-4b72-96e9-e1b4604a3549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norav
• Version Model Number: 99-0233-10
• Catalog Number: NBP-ONE-K-00-01
• 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: true
• 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: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com
• Phone: +1-313-654-2300
• Email: UDI_Mail@suntechmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935108702 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-06-14

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• 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