247

GUDID 10840935106678

SUNTECH MEDICAL, INC.

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• Primary Device ID: 10840935106678
• NIH Device Record Key: 8384aa7c-9e0a-42d1-83d9-8434cf7bebfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 247
• Version Model Number: 99-0102-00
• 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: 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: +1-919-654-2300
• 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
• 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	10840935106678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070750

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: 2020-09-09
• Device Publish Date: 2016-09-12

On-Brand Devices [247]

• 10840935106760: 99-0121-00
• 10840935106753: 99-0120-00
• 10840935106746: 99-0119-00
• 10840935106739: 99-0118-00
• 10840935106722: 99-0117-00
• 10840935106715: 99-0116-00
• 10840935106708: 99-0106-00
• 10840935106692: 99-0104-00
• 10840935106685: 99-0103-00
• 10840935106678: 99-0102-00
• 10840935106661: 99-0100-00
• 10840935106654: 99-0099-00
• 10840935106647: 99-0098-00
• 10840935106630: 99-0096-00
• 10840935106623: 99-0094-00
• 10840935106616: 99-0093-00
• 10840935106609: 99-0090-00
• 10840935106593: 99-0068-00
• 10840935106562: 98-0230-00
• 10840935105848: 99-0124-00
• 10840935105831: 99-0105-00
• 10840935105824: 99-0101-00
• 10840935105817: 99-0097-00
• 10840935105800: 99-0095-00
• 10840935105794: 99-0092-00
• 10840935105787: 99-0091-00
• 10840935105770: 99-0089-00
• 10840935105671: 99-0085-00
• 10840935105664: 99-0084-00
• 10840935105657: 99-0072-00
• 10840935105640: 99-0071-00
• 10840935105633: 99-0070-00
• 10840935105626: 99-0069-00
• 10840935105619: 99-0067-00
• 10840935105602: 99-0066-00
• 10840935105596: 99-0065-00
• 10840935105589: 99-0064-00
• 10840935105572: 99-0063-00
• 10840935105565: 99-0062-00
• 10840935105558: 99-0061-00
• 10840935102717: 98-0155-00
• 10840935102601: 98-0129-00
• 10840935102595: 98-0128-00