BioTab

GUDID 10810113578245

BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Medium)

VIVE HEALTH LLC

Multi-chamber venous compression system garment, reusable
Primary Device ID10810113578245
NIH Device Record Keyf2e5d62c-3868-49db-83eb-c2c87545504c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioTab
Version Model NumberRHB3023SLEM
Company DUNS047025993
Company NameVIVE HEALTH LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113578248 [Primary]
GS110810113578245 [Package]
Contains: 00810113578248
Package: Case [6 Units]
In Commercial Distribution

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-28
Device Publish Date2024-08-20

On-Brand Devices [BioTab]

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

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