BioTab

GUDID 10810113576951

BT Lymphedema Pump (PCD) 8 Chamber (Small)

VIVE HEALTH LLC

Sequential venous compression system

• Primary Device ID: 10810113576951
• NIH Device Record Key: 31ba4b2d-d0b8-4305-82d6-b57712e1b742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTab
• Version Model Number: RHB3023BLKS
• 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	00810113576954 [Primary]
GS1	10810113576951 [Package]; Contains: 00810113576954; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201982

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [BioTab ]

• 10810113578252: BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Medium Wide)
• 10810113578245: BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Medium)
• 10810113578238: BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Small)
• 10810113576975: BT Lymphedema Pump (PCD) 8 Chamber (Medium WIde)
• 10810113576968: BT Lymphedema Pump (PCD) 8 Chamber (Medium)
• 10810113576951: BT Lymphedema Pump (PCD) 8 Chamber (Small)