Disposable Cuff

GUDID 10840935105022

SUNTECH MEDICAL, INC.

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• Primary Device ID: 10840935105022
• NIH Device Record Key: 3d0ea8a1-4e08-4aeb-a260-027fcb6c0b9a
• Commercial Distribution Discontinuation: 2017-05-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Disposable Cuff
• Version Model Number: 98-0700-04
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 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
• Phone: 919-654-2300
• Email: UDI_MAIL@suntechmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935105022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080854

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2019-07-22
• Device Publish Date: 2016-09-12

On-Brand Devices [Disposable Cuff]

• 10840935106371: 98-0399-26
• 10840935106128: 98-0399-56
• 10840935106111: 98-0399-57
• 10840935105138: 98-0799-17
• 10840935105084: 98-0799-07
• 10840935104230: 98-0799-87
• 10840935103844: 98-0399-A6
• 10840935103752: 97-1108-03
• 10840935103684: 98-0799-86
• 10840935103639: 98-0399-D7
• 10840935103622: 98-0399-D6
• 10840935103141: 98-0399-37
• 10840935103134: 98-0399-36
• 10840935102366: 98-0799-77
• 10840935102304: 98-0799-76
• 10840935100850: 98-0399-G6
• 10840935100843: 98-0399-G7
• 10840935100652: 98-0799-47
• 10840935100645: 98-0799-46
• 10840935100515: 98-0799-37
• 10840935100492: 98-0799-36
• 10840935100331: 98-0799-27
• 10840935100317: 98-0799-26
• 10840935100072: 98-0799-16
• 10840935100027: 98-0799-06
• 20840935107658: 98-0399-C8
• 10840935106364: 98-0399-28
• 10840935106265: 98-0400-38
• 10840935106081: 98-0399-58
• 10840935104247: 98-0799-88
• 10840935103646: 98-0399-D8
• 10840935102397: 98-0799-78
• 10840935100805: 98-0399-A8
• 10840935100782: 98-0399-G8
• 10840935100669: 98-0799-48
• 10840935100539: 98-0799-38
• 10840935100348: 98-0799-28
• 10840935100324: 98-0399-78
• 10840935100119: 98-0799-18
• 10840935100034: 98-0799-08
• 20840935108402: 97-1108-12
• 20840935108396: 97-1108-11
• 20840935108389: 97-1108-10
• 20840935108372: 97-1108-09
• 20840935108211: 98-0399-7K
• 20840935108204: 98-0399-5K
• 20840935108198: 98-0399-2K
• 20840935108181: 98-0399-1K
• 20840935108174: 98-0399-0K
• 20840935108167: 98-0799-6K