PremierPro

GUDID 10818566012941

Sphygmomanometer, Wall Unit w/ Stand

PRESTIGE AMERITECH, LTD.

Aneroid manual sphygmomanometer

• Primary Device ID: 10818566012941
• NIH Device Record Key: 9140c543-dc76-413d-b115-f6cea12a90df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremierPro
• Version Model Number: 6106
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818566012941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092245

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: 2026-03-23
• Device Publish Date: 2016-06-01

Devices Manufactured by PRESTIGE AMERITECH, LTD.

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