All Purpose Cuff

GUDID 10840935102793

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935102793
• NIH Device Record Key: 34177d1f-0eb5-4f5b-a9ad-18cddf10371f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Purpose Cuff
• Version Model Number: 98-0234-03
• 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: false
• 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
• 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	10840935102793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010622

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 [All Purpose Cuff]

• 10840935108016: 98-0096-03
• 10840935108009: 98-0100-03
• 10840935107699: 98-0101-03
• 10840935107682: 98-0098-03
• 10840935107460: 98-0085-80
• 10840935107453: 98-0085-79
• 10840935107446: 98-0085-78
• 10840935107439: 98-0085-77
• 10840935107422: 98-0085-74
• 10840935107415: 98-0085-70
• 10840935107408: 98-0085-69
• 10840935107392: 98-0085-68
• 10840935107385: 98-0085-67
• 10840935107378: 98-0085-64
• 10840935107361: 98-0085-50
• 10840935107354: 98-0085-49
• 10840935107347: 98-0085-48
• 10840935107330: 98-0085-47
• 10840935107323: 98-0085-46
• 10840935107316: 98-0085-44
• 10840935107309: 98-0085-40
• 10840935107293: 98-0035-39
• 10840935107286: 98-0085-38
• 10840935107279: 98-0085-37
• 10840935107262: 98-0085-36
• 10840935107255: 98-0085-34
• 10840935107248: 98-0084-80
• 10840935107231: 98-0084-79
• 10840935107224: 98-0084-77
• 10840935107217: 98-0084-50
• 10840935107200: 98-0084-40
• 10840935107194: 98-0084-39
• 10840935107187: 98-0082-10
• 10840935107170: 98-0082-04
• 10840935107163: 98-0095-19
• 10840935106517: 98-0085-27
• 10840935106500: 98-0085-24
• 10840935106494: 98-0085-29
• 10840935106487: 98-0085-25
• 10840935106470: 98-0085-23
• 10840935106463: 98-0085-22
• 10840935106456: 98-0085-21
• 10840935102748: 98-0224-00
• 10840935102731: 98-0223-00
• 10840935102588: 98-0118-01
• 10840935102571: 98-0117-01
• 10840935102564: 98-0115-01
• 10840935102557: 98-0114-01
• 10840935102540: 98-0113-01
• 10840935102533: 98-0101-02