Durable Cuff

GUDID 10840935108108

SUNTECH MEDICAL, INC.

Blood pressure cuff, reusable

• Primary Device ID: 10840935108108
• NIH Device Record Key: 91e34e7c-349c-4a8e-8401-2078f16938e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durable Cuff
• Version Model Number: 98-0599-5K
• 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
• 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	10840935108108 [Primary]
GS1	20840935108105 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051904

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: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-11-30

Devices Manufactured by SUNTECH MEDICAL, INC.

• 10840935110477 - Skanray: 2024-06-28
• 10840935110217 - ProLife: 2023-06-19
• 10840935110224 - SunTech APC: 2023-06-19
• 10840935110231 - ProLife: 2023-06-19
• 10840935110248 - ProLife: 2023-06-19
• 10840935110255 - ProLife: 2023-06-19
• 10840935110262 - ProLife: 2023-06-19
• 10840935110279 - SunTech APC: 2023-06-19