TeleRPM Blood Glucose Monitoring System

GUDID 00860004687535

Remote Patient Devices LLC

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Primary Device ID00860004687535
NIH Device Record Key5bd733d9-1390-4c58-b6ce-d8351cf540ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeleRPM Blood Glucose Monitoring System
Version Model NumberTMB-2282-G
Company DUNS121900487
Company NameRemote Patient Devices LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100860004687535 [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 Date2024-01-31
Device Publish Date2024-01-23

Devices Manufactured by Remote Patient Devices LLC

00860004687535 - TeleRPM Blood Glucose Monitoring System 2024-01-31
00860004687535 - TeleRPM Blood Glucose Monitoring System 2024-01-31
00860004687542 - TeleRPM Blood Glucose Meter2024-01-31
00860004687559 - TeleRPM Blood Glucose Test Strip 2024-01-31
00860004687566 - Control Solution 2024-01-31
00860004687573 - Single Use Lancets2024-01-31
00860004687580 - Lancing Device2024-01-31
00860004687528 - Pro Cellular Blood Pressure Monitor2022-01-10

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