Durable BP Cuff

GUDID 10840935108849

SUNTECH MEDICAL, INC.

Blood pressure cuff, reusable

• Primary Device ID: 10840935108849
• NIH Device Record Key: 4a5db26e-cff1-4529-94cf-90b497569b80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durable BP Cuff
• Version Model Number: 98-0599-EK
• 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
• 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	10840935108849 [Primary]
GS1	20840935108846 [Package]; Package: [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [Durable BP Cuff]

• 10840935104209: 98-0599-49
• 10840935107958: 98-0607-01
• 10840935105404: 98-0599-F6
• 10840935104735: 98-0599-F7
• 10840935104636: 98-0599-D7
• 10840935104629: 98-0599-D6
• 10840935104117: 98-0599-37
• 10840935104100: 98-0599-36
• 10840935103981: 98-0599-17
• 10840935103974: 98-0599-16
• 10840935100362: 98-0599-26
• 10840935104933: 98-0608-05
• 10840935104919: 98-0608-02
• 10840935104902: 98-0608-01
• 10840935105435: 98-0599-F8
• 10840935103998: 98-0599-18
• 10840935100249: 98-0599-38
• 10840935107965: 98-0609-01
• 10840935104957: 98-0609-05
• 10840935108535: 98-0610-06
• 10840935108528: 98-0608-06
• 10840935108511: 98-0606-06
• 10840935108504: 98-0604-06
• 10840935108412: 98-0602-06
• 20840935108266: 98-0599-4K
• 20840935108259: 98-0599-3K
• 20840935108242: 98-0599-2K
• 20840935108235: 98-0599-1K
• 20840935108228: 98-0599-0K
• 10840935108146: 98-060C-06
• 10840935108139: 98-060A-06
• 20840935108129: 98-0599-6K
• 10840935108078: 98-060K-01
• 10840935107989: 98-0610-01
• 10840935107972: 98-060C-01
• 10840935107156: 98-0600-80
• 10840935107149: 98-0600-88
• 10840935107132: 98-0600-87
• 10840935107125: 98-0600-81
• 10840935107095: 98-0600-89
• 10840935107088: 98-0600-83
• 10840935107019: 98-0600-86
• 10840935107002: 98-0600-85
• 10840935106852: 98-0599-GC
• 10840935106845: 98-0599-GA
• 10840935106838: 98-0599-G9
• 10840935106319: 98-0599-G8
• 10840935106036: 98-0599-G7
• 10840935105992: 98-0599-G6
• 10840935105534: 98-0599-G3