BioTel Care BGM 4 TM0009

GUDID 00859519002391

BioTel Care BGM 4

TELCARE, LLC

Glucose monitoring system IVD, home-use
Primary Device ID00859519002391
NIH Device Record Keyfb122ebf-a99b-4a94-a528-e12a4081195a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioTel Care BGM 4
Version Model NumberTM0009
Catalog NumberTM0009
Company DUNS116979417
Company NameTELCARE, 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 Batchfalse
Serial Numbertrue
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
GS100859519002391 [Package]
Contains: 00859519002407
Package: [1 Units]
In Commercial Distribution
GS100859519002407 [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 Date2021-01-25
Device Publish Date2021-01-16

Devices Manufactured by TELCARE, LLC

00859519002391 - BioTel Care BGM 42021-01-25BioTel Care BGM 4
00859519002391 - BioTel Care BGM 42021-01-25 BioTel Care BGM 4
00859519002261 - BioTel Care® Test Strips2019-03-19 Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution.
10859519002053 - BioTel Care® Double Control Solution 2019-03-19 Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.
00859519002223 - BioTel Care® Blood Glucose Monitoring System2019-03-19 The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2).
00859519002247 - Telserve® Data Management System2019-03-19 The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.