FDA.reportPublic FDA data

BioTel Care® Blood Glucose Monitoring System

Primary DI
00859519002223
Brand
BioTel Care® Blood Glucose Monitoring System
Company
TELCARE, LLC
Model
BGM
Catalog number
TM0008
Device description
The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). The BioTel Care® Blood Glucose Meter, when used with the BioTel Care® Blood Glucose Test Strip, quantitatively measures glucose in capillary whole blood. The BioTel Care® Glucose Control Solutions are used by patients to verify the performance of the BioTel Care® test strips and BioTel Care® meter.
Published
2019-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110571000TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USETelcare, Inc.2011-07-28NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859519002339PackageGS116In Commercial Distribution
00859519002223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859519002339008595190023398595190023390859519002339
00859519002223008595190022238595190022230859519002223

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-777-4710support@telcare.com

Regulatory Flags#

DUNS number
116979417
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859519002018BioTel Care® Test StripsTSTT00032019-03-11
00859519002056BioTel Care® Double Control Solution CSTC00032019-03-11
00859519002407BioTel Care BGM 4TM0009TM00092021-01-16
00859519002247Telserve® Data Management SystemDMS2019-03-11
00859519002391BioTel Care BGM 4TM0009TM00092021-01-16
00859519002261BioTel Care® Test StripsTSTT00032019-03-11
10859519002053BioTel Care® Double Control Solution CSTC00032019-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
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10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
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10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
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