VivePro

GUDID 10810041988567

Ultrasound Gel 5L + 250ml Refill Bottle

VIVE HEALTH LLC

Coupling gel, non-sterile

• 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

• 00810113579757 - Vive: 2025-04-15 Urinary Drainage Bag (Bedside)
• 10810113579761 - Vive: 2025-04-15 Urinary Drainage Bag (Bedside) 5PK
• 10810113579976 - Vive: 2025-04-15 Urinary Drainage Bag (Leg)
• 10810113579983 - Vive: 2025-04-15 Urinary Drainage Bag (Leg) 3PK
• 10810113578283 - Vive Mobility: 2025-04-14 Bariatric Carbon Fiber Rollator
• 10810113579624 - Vive: 2025-04-14 Catheter Leg Bag Holder (Small)
• 10810113579631 - Vive: 2025-04-14 Catheter Leg Bag Holder (Medium)
• 10810113579648 - Vive: 2025-04-14 Catheter Leg Bag Holder (Large)