SunTech

GUDID 10840935108634

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935108634
• NIH Device Record Key: 3c0df55e-13d3-446e-ae8f-fccf304026f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunTech
• Version Model Number: 98-0252-00
• 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: true
• 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	10840935108634 [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: 2019-05-31

On-Brand Devices [SunTech]

• 10840935108566: 98-0030-03
• 10840935108603: 98-0239-34
• 10840935108597: 98-0239-33
• 10840935108580: 98-0239-32
• 10840935108573: 98-0239-31
• 10840935108832: 91-0028-15
• 10840935109006: 98-0239-54
• 10840935108993: 98-0239-53
• 10840935108986: 98-0239-52
• 10840935108979: 98-0239-51
• 10840935108962: 98-0239-24
• 10840935108955: 98-0239-23
• 10840935108948: 98-0239-22
• 10840935108931: 98-0239-21
• 10840935108924: 98-0239-14
• 10840935108917: 98-0239-13
• 10840935108900: 98-0239-12
• 10840935108894: 98-0239-11
• 10840935108887: 98-0238-44
• 10840935108870: 98-0239-43
• 10840935108863: 98-0239-42
• 10840935108856: 98-0239-41
• 10840935108689: 98-0254-01
• 10840935108672: 98-0254-00
• 10840935108665: 98-0253-01
• 10840935108658: 98-0253-00
• 10840935108641: 98-0252-01
• 10840935108634: 98-0252-00
• 10840935108627: 98-0251-01
• 10840935108610: 98-0251-00
• 10840935109105: 98-0239-64
• 10840935109099: 98-0239-63
• 10840935109082: 98-0239-62
• 10840935109075: 98-0239-61
• 10840935106302: 52-0010-00
• 10840935106258: 52-0005-00
• 10840935106210: 52-0005-01
• 10840935109464: 91-0087-00
• 10840935109600: 98-0101-24
• 10840935109594: 98-0068-99
• 10840935109587: 98-0099-34
• 10840935109570: 98-0097-44
• 10840935109563: 98-0095-24
• 10840935109556: 98-0093-23
• 10840935109624: 91-0143-00
• 10840935109648: 98-0068-19
• 10840935109631: 98-0068-10
• 10840935109693: 99-0027-39
• 10840935109914: 99-0088-12
• 10840935109983: 99-0233-71