BioTel Care® Double Control Solution TC0003

GUDID 10859519002053

Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.

TELCARE, LLC

Glucose IVD, control
Primary Device ID10859519002053
NIH Device Record Keyc8232364-f735-4768-8f9e-36a411da9492
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioTel Care® Double Control Solution
Version Model NumberCS
Catalog NumberTC0003
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone877-777-4710
Emailsupport@telcare.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100859519002056 [Primary]
GS110859519002053 [Package]
Contains: 00859519002056
Package: [260 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-19
Device Publish Date2019-03-11

Devices Manufactured by TELCARE, LLC

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 2019-03-19Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.
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

Trademark Results [BioTel Care]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOTEL CARE
BIOTEL CARE
87738424 5704590 Live/Registered
Telcare, LLC
2017-12-29
BIOTEL CARE
BIOTEL CARE
87738418 5619015 Live/Registered
Telcare, LLC
2017-12-29

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