Orbit-K

GUDID 10840935110033

SUNTECH MEDICAL, INC.

Blood pressure cuff, reusable

• Primary Device ID: 10840935110033
• NIH Device Record Key: 0a5a7026-6f25-403f-93a8-a5c4b75145c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbit-K
• Version Model Number: 98-0061-21
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935110033 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-10
• Device Publish Date: 2023-03-02

On-Brand Devices [Orbit-K]

• 10840935110101: 98-0061-22
• 10840935110095: 98-0061-20
• 10840935110088: 98-0061-19
• 10840935110071: 98-0061-18
• 10840935110064: 98-0061-17
• 10840935110057: 98-0061-16
• 10840935110040: 98-0061-23
• 10840935110033: 98-0061-21
• 10840935110149: 98-0062-31
• 10840935110132: 98-0062-30
• 10840935110125: 98-0062-33
• 10840935110118: 98-0062-32