Vinyl Cuff

GUDID 20840935108310

SUNTECH MEDICAL, INC.

Blood pressure cuff, reusable

• Primary Device ID: 20840935108310
• NIH Device Record Key: 45782e9e-1121-4f6e-ae95-77b89ccb10e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vinyl Cuff
• Version Model Number: 98-0799-4K
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935108313 [Primary]
GS1	20840935108310 [Package]; Contains: 10840935108313; Package: Box [20 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-12-07

On-Brand Devices [Vinyl Cuff]

• 20840935108310: 98-0799-4K
• 20840935108303: 98-0799-3K
• 20840935108297: 98-0799-2K
• 20840935108280: 98-0799-1K
• 20840935108273: 98-0799-0K