Eclipse Cuff

GUDID 10840935107743

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935107743
• NIH Device Record Key: 7109f48a-1642-4e1a-8164-6f98480a521b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Cuff
• Version Model Number: 98-0068-98
• 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: 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
• 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	10840935107743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003004

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: 2017-05-26

On-Brand Devices [Eclipse Cuff]

• 10840935107743: 98-0068-98
• 10840935107736: 98-0068-97
• 10840935107729: 98-0068-09
• 10840935107712: 98-0068-08
• 10840935107705: 98-0068-07
• 10840935107675: 98-0068-06