BPL

GUDID 10840935109136

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935109136
• NIH Device Record Key: f95886cb-6d9a-4c2b-be4d-9628228bc06b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPL
• Version Model Number: 98-1020-05
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935109136 [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: 2020-05-15
• Device Publish Date: 2020-05-07

On-Brand Devices [BPL]

• 10840935109150: 91-0143-05
• 10840935109143: 91-0032-83
• 10840935109136: 98-1020-05
• 10840935109129: 98-0037-05
• 10840935109112: 98-0036-05
• 10840935109068: 99-0233-60