TeleMate Health &TeleRPM TMB-2282-G

GUDID 00850042929438

TeleRPM Blood Glucose Monitoring System

Mio Labs Inc.

Blood glucose/blood pressure monitoring system, home-use
Primary Device ID00850042929438
NIH Device Record Keyb107aa74-9733-4e10-8505-faa7020e3124
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeleMate Health &TeleRPM
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
GS100850042929438 [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 [TeleMate Health &TeleRPM]

00850042929438TeleRPM Blood Glucose Monitoring System
00850042929421Lancing Device
00850042929414Single Use Lancets
00850042929407Control Solution
00850042929391Blood Glucose Test Strip
00850042929384TeleRPM Blood Glucose Meter

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