Nonin

GUDID 10840935106227

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 10840935106227
• NIH Device Record Key: 3da5ea1c-c38f-4c9e-8a47-b0dec557f7bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nonin
• Version Model Number: 52-0003-00
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935106227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122401

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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-12

On-Brand Devices [Nonin]

• 10840935106227: 52-0003-00
• 10840935102762: 98-0233-01
• 10840935102755: 98-0233-00