Tango M2 Patient Cable, RoHS

GUDID 10840935108047

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 10840935108047
• NIH Device Record Key: 75ee84b6-6d0c-4d81-b75f-268698578047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tango M2 Patient Cable, RoHS
• Version Model Number: 91-0127-02
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935108047 [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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-08-16

On-Brand Devices [Tango M2 Patient Cable, RoHS]

• 10840935108047: 91-0127-02
• 10840935107767: 91-0127-01