Orbit K

GUDID 10840935100997

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 10840935100997
• NIH Device Record Key: 4f0b172b-136f-43b9-bcdd-4fbc03abf2be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbit K
• Version Model Number: 98-0062-21
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935100997 [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: 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 K]

• 10840935108023: 98-0062-26
• 10840935101024: 98-0062-25
• 10840935101017: 98-0062-23
• 10840935101000: 98-0062-22
• 10840935100997: 98-0062-21
• 10840935100980: 98-0062-05
• 10840935100973: 98-0062-03
• 10840935100966: 98-0062-02
• 10840935100959: 98-0062-01
• 10840935100942: 98-0061-05
• 10840935100935: 98-0061-03
• 10840935100928: 98-0061-02
• 10840935100911: 98-0061-01
• 10840935109488: 98-0061-25
• 10840935109549: 98-0062-37
• 10840935109532: 98-0062-36
• 10840935109525: 98-0.062-35
• 10840935109518: 98-0062-34
• 10840935109501: 98-0061-27
• 10840935109495: 98-0061-26
• 10840935109471: 98-0061-24