Orbit

GUDID 10840935101062

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder

• Primary Device ID: 10840935101062
• NIH Device Record Key: 50e5be1b-def7-4018-8854-8c2e391afa63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbit
• Version Model Number: 98-0063-14
• 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	10840935101062 [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