Tango M2

GUDID 10840935102816

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 10840935102816
• NIH Device Record Key: 5ff647de-884a-4b3b-a4b1-dd160223af92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tango M2
• Version Model Number: 98-0235-01
• 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: 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: +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	10840935102816 [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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-12

On-Brand Devices [Tango M2]

• 10840935108726: 99-0088-51
• 10840935107996: 99-0088-50
• 10840935107477: 99-0132-16
• 10840935106777: 99-0132-01
• 10840935105961: 99-0132-20
• 10840935105954: 99-0132-19
• 10840935105947: 99-0132-18
• 10840935105930: 99-0132-17
• 10840935105923: 99-0132-11
• 10840935105916: 99-0132-10
• 10840935105909: 99-0132-09
• 10840935105893: 99-0132-07
• 10840935105886: 99-0132-06
• 10840935105879: 99-0132-05
• 10840935105862: 99-0132-04
• 10840935105855: 99-0132-00
• 10840935105763: 99-0088-41
• 10840935105756: 99-0088-40
• 10840935105749: 99-0088-20
• 10840935105732: 99-0088-15
• 10840935105725: 99-0088-14
• 10840935105718: 99-0088-03
• 10840935105701: 99-0088-02
• 10840935105695: 99-0088-01
• 10840935105688: 99-0088-00
• 10840935105329: 98-1010-00
• 10840935105312: 98-1009-00
• 10840935102816: 98-0235-01
• 10840935102809: 98-0235-00
• 10840935110019: 98-1010-00