Orbit

GUDID 10840935101048

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935101048
• NIH Device Record Key: 129cec33-7173-4717-89dc-71a5e7634dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbit
• Version Model Number: 98-0063-12
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935101048 [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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-12

On-Brand Devices [Orbit]

• 10840935102472: 98-0125-04
• 10840935102465: 98-0125-03
• 10840935102441: 98-0124-04
• 10840935102434: 98-0124-03
• 10840935102410: 98-0123-04
• 10840935102403: 98-0123-03
• 10840935102380: 98-0122-04
• 10840935102373: 98-0122-03
• 10840935101062: 98-0063-14
• 10840935101055: 98-0063-13
• 10840935101048: 98-0063-12
• 10840935101031: 98-0063-11