FDA.reportPublic FDA data

BLE Smart® Test Strips

Primary DI
00850081003960
Brand
BLE Smart® Test Strips
Company
ENTRA HEALTH SYSTEMS LLC
Model
BLE-TS50-FDA
Device description
Glucose Test Strips
Published
2017-01-27
Public version status
Update
Distribution status
Not 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
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160365000BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.2016-09-28NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850081003960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850081003960008500810039608500810039600850081003960

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
619-684-6232support@entrahealth.com

Regulatory Flags#

DUNS number
826314044
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850081003011MyGlucoHealth Test StripsMGH-TS50-FDA2018-11-19
10852668007016BLE Smart Test StripBLE-SMART-TS50-FDA2019-02-05
00850081003014MyGlucoHealth® Test StripsMGH-TS502017-01-27
00850081003007MyGlucoHealth® BT Meter KitMGH-BT12017-01-27
00850081003038MyGlucoHealth LancetsMGH-LCT1002018-09-24
00850081003212MyGlucoHealth® Control Solution 3-PackMGH-CS32018-09-24
00852668007019BLE Smart® Test StripsBLE-TS50-FDA2017-02-23
00852668007040MyGlucoHealth® Wireless Blood Glucose SystemMGH-CL12017-04-07
00852668007057MyGlucoHealth® Wireless Blood Glucose MeterMGH-CL12017-04-07
00852668007064BLE Smart® Blood Glucose SystemBLE-SMART-METER-FDA2017-01-27
00852668007071BLE Smart® Blood Glucose MeterBLE-SMART-METER2017-01-27
00852668007095MyGlucoHealth® BT MeterMGH-BT12017-01-27
00852668007187BLE Smart® Control SolutionBLE-CS32018-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
00301939628021CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2025-01-06
00353885012836OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2024-01-31
00850044118250iHealthiHealth Labs Inc.LFR2023-08-30
00850044118267iHealthiHealth Labs Inc.LFR2023-08-30
00850044118205iHealthiHealth Labs Inc.LFR2023-08-24
00353885012799OneTouch Verio FlexLifeScan Europe GmbHLFR2023-05-26
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
00353885012102OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012621OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012638OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012645OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012683OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012485OneTouch Verio FlexLifeScan Europe GmbHLFR2022-05-19
00301937828010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2022-01-07
00301939550018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-12-08
00301937825019CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-11-22
00353885012423OneTouch VerioLifeScan Europe GmbHLFR2021-09-18
00021292014797TRUE METRIXTRIVIDIA HEALTH, INC.LFR2021-08-06
00301937553011CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2021-07-30
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
00353885012188OneTouch VerioLifeScan Europe GmbHLFR2020-06-30
50096295139551TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-05-11
00357599807009FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00357599808006FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00353885012034OneTouch VerioLifeScan Europe GmbHLFR2020-04-12