TeleRPM / Chronica TMB-2282-G

GUDID 00850042929193

TeleRPM Blood Glucose Meter

Mio Labs Inc.

Blood glucose/blood pressure monitoring system, home-use
Primary Device ID00850042929193
NIH Device Record Key218f97a5-64ec-4ef2-a6db-1b8621f964d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeleRPM / Chronica
Version Model NumberTeleBGM 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 Kitfalse
Device Combination Productfalse
Single Usetrue
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042929193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-14
Device Publish Date2023-09-06

On-Brand Devices [TeleRPM / Chronica]

00850042929230Lancing Device
00850042929223Single Use Lancets
00850042929216TeleRPM Control Solution
00850042929247TeleRPM Blood Glucose Monitoring System
00850042929209TeleRPM Blood Glucose Test Strip
00850042929193TeleRPM Blood Glucose Meter

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