VivePro

GUDID 10810041988567

Ultrasound Gel 5L + 250ml Refill Bottle

VIVE HEALTH LLC

Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• Primary Device ID: 10810041988567
• NIH Device Record Key: 3976c831-c0ef-457f-98fe-d72bb6a6b4f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivePro
• Version Model Number: RHB1088SET
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00810041988560 [Primary]
GS1	10810041988567 [Package]; Contains: 00810041988560; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101952

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2021-12-17
• Device Publish Date: 2021-12-09

Devices Manufactured by VIVE HEALTH LLC

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• 10818323027645 - VIVE: 2024-03-20 Neck Brace (Beige) V2
• 10810041986655 - VIVE: 2024-03-18 Stabilizing Elbow Brace
• 10810041987690 - ARCTIC FLEX: 2024-03-18 LSO Ice Packs
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• 10810113576173 - Vive: 2024-03-18 Folding Cane Grey Poly