Health Wealth Safe TMB-2282-G

GUDID 00850042929377

TeleRPM Blood Glucose Monitoring System

Mio Labs Inc.

Blood glucose/blood pressure monitoring system, home-use
Primary Device ID00850042929377
NIH Device Record Key78bccc65-330c-4a94-a390-e535cc5d7279
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Wealth Safe
Version Model NumberTMB-2282-G
Catalog NumberTMB-2282-G
Company DUNS117119317
Company NameMio Labs Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042929377 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

On-Brand Devices [Health Wealth Safe]

00850042929377TeleRPM Blood Glucose Monitoring System
00850042929360Lancing Device
00850042929353Single Use Lancets
00850042929346Control Solution
00850042929339Blood Glucose Test Strip
00850042929322TeleRPM Blood Glucose Meter

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