Oscar 2, Model 250D

GUDID 10840935108467

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935108467
• NIH Device Record Key: b8344799-9f82-419f-a557-cbff81bee746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oscar 2, Model 250D
• Version Model Number: 99-0233-04
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com
• Phone: 919-654-2300
• Email: udi_mail@suntechmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935108467 [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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-04-06

On-Brand Devices [Oscar 2, Model 250D]

• 10840935108498: 99-0233-07
• 10840935108481: 99-0233-06
• 10840935108474: 99-0233-05
• 10840935108467: 99-0233-04
• 10840935108450: 99-0233-03
• 10840935108443: 99-0223-02
• 10840935108436: 99-0233-01
• 10840935108429: 99-0233-00