Home GUDID 00859519002391 BioTel Care BGM 4
Primary DI 00859519002391
Brand BioTel Care BGM 4
Company TELCARE, LLC
Model TM0009
Catalog number TM0009
Device description BioTel Care BGM 4
Published 2021-01-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00859519002391 Package GS1 1 In Commercial Distribution 00859519002407 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00859519002391 00859519002391 859519002391 0859519002391 00859519002407 00859519002407 859519002407 0859519002407
GMDN Terms# Term, Definition table Term Definition Glucose monitoring system IVD, home-use A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Regulatory Flags# DUNS number 116979417 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00859519002018 BioTel Care® Test Strips TS TT0003 2019-03-11 00859519002056 BioTel Care® Double Control Solution CS TC0003 2019-03-11 00859519002407 BioTel Care BGM 4 TM0009 TM0009 2021-01-16 00859519002223 BioTel Care® Blood Glucose Monitoring System BGM TM0008 2019-03-11 00859519002247 Telserve® Data Management System DMS 2019-03-11 00859519002261 BioTel Care® Test Strips TS TT0003 2019-03-11 10859519002053 BioTel Care® Double Control Solution CS TC0003 2019-03-11
Other Devices Sharing Product Codes#