Vive

GUDID 10810113574902

Blood Pressure Monitor (White)

VIVE HEALTH LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10810113574902
• NIH Device Record Key: a80bbe7a-4bca-43ec-a5b6-8d741079f212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vive
• Version Model Number: DMD1087WHT
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113574905 [Primary]
GS1	10810113574902 [Package]; Contains: 00810113574905; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222125

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2024-01-22
• Device Publish Date: 2024-01-12

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• 10818323026051: Toe Separators Green
• 10818323026044: Folding Cane Teal
• 10818323026037: Folding Cane Purple
• 10818323026020: Wrist Brace Right
• 10818323026013: Wrist Brace Left
• 10818323026006: Bamboo Wrist Small
• 10818323025993: Bamboo Wrist Large
• 10818323025986: Bamboo Elbow Small
• 10818323025979: Bamboo Elbow Large
• 10818323025962: Bamboo Ankle Small
• 10818323025955: Bamboo Ankle Large
• 10818323025948: Bamboo Knee Small
• 10818323025931: Bamboo Knee Medium
• 10818323025924: Bamboo Knee Large
• 10818323025900: Universal Arm Sling
• 10818323025894: Hernia Belt - Small
• 10818323025887: Hernia Belt - Medium
• 10818323025870: Hernia Belt Large
• 10818323025863: Posture Corrector -Small OLD
• 10818323025856: Posture Corrector Large-OLD
• 10818323025849: Hinged Knee Brace
• 10818323025832: Elbow Brace
• 10818323025825: Shoulder Support
• 10818323025818: Back Brace Black
• 10818323025801: Ankle Brace
• 10818323025795: Neck Brace Black
• 10818323025788: Neck Brace- White
• 10818323025771: Tennis Elbow
• 10818323025764: Calf Support
• 10818323025757: Waist Trimmer
• 00818323025729: Patella Knee Strap
• 00818323025569: Groin Support
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• 10818323024958: Thumb Brace
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• 00818323022926: Arch Support
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• 10818323021766: Wireless Tens Unit
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• 10818323021490: Neck Brace Small White