BioTab

GUDID 10810178881168

BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Small)

VIVE HEALTH LLC

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 10810178881168
• NIH Device Record Key: fd82ebd2-62ad-4afd-8d7a-f9e0c0d985c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTab
• Version Model Number: RHB3044S2PAK
• Company DUNS: 047025993
• Company Name: VIVE HEALTH LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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	00810178881161 [Primary]
GS1	10810178881168 [Package]; Contains: 00810178881161; Package: Case [8 Units]; In Commercial Distribution

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: 2024-12-10
• Device Publish Date: 2024-12-02

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)
• 10810178881182: BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Medium Wide)
• 10810178881175: BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Mediuml)
• 10810178881168: BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Small)
• 10810178880888: BT Lymphedema Pump (PCD) 8 Chamber (Extra Wide)
• 10810178880871: BT Lymphedema Pump (PCD) 8 Chamber (Large)
• 10810178880864: BT Lymphedema Pump (PCD) 8 Chamber (Small Wide)