Oscar 2

GUDID 10840935107491

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935107491
• NIH Device Record Key: 2a627f07-2d00-4ea4-97c1-1d50ab37a4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oscar 2
• Version Model Number: 99-0133-11
• 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: false
• Serial Number: true
• 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	10840935107491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151520

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: 2017-06-10

On-Brand Devices [Oscar 2]

• 10840935102854: 98-0239-04
• 10840935102847: 98-0239-03
• 10840935102830: 98-0239-02
• 10840935102823: 98-0239-01
• 10840935108818: 99-0133-07
• 10840935108801: 99-0133-06
• 10840935108795: 99-0133-05
• 10840935108788: 99-0133-04
• 10840935107514: 99-0133-13
• 10840935107507: 99-0133-12
• 10840935107491: 99-0133-11
• 10840935107484: 99-0133-10
• 10840935106791: 99-0133-03
• 10840935106784: 99-0133-01
• 10840935105985: 99-0133-02
• 10840935105978: 99-0133-00
• 10840935105374: 99-0012-41
• 10840935105367: 99-0012-29
• 10840935105343: 99-0012-09
• 10840935105336: 99-0012-00
• 10840935109655: 99-0133-50
• 10840935109952: 99-0133-17
• 10840935109945: 99-0133-16
• 10840935109938: 99-0133-15
• 10840935109921: 99-0133-14