FDA.reportPublic FDA data

Clever Choice

Primary DI
00898302001289
Brand
Clever Choice
Company
SIMPLE DIAGNOSTICS INC
Model
Pro Strips
Catalog number
98302-0001-28
Device description
Blood Glucose Test Strips for Clever Choice Pro and Mini Blood Glucose Meters.
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898302001286PackageGS1400In Commercial Distribution
00898302001289PrimaryGS10
20898302001283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089830200128610898302001286
00898302001289008983020012898983020012890898302001289
2089830200128320898302001283

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care blood glucose monitoring system IVDA 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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature39 Degrees Fahrenheit104 Degrees Fahrenheit

Regulatory Flags#

DUNS number
004135503
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898302140230Comfort EZ Safety LancetCLES1002398302-0140-232025-11-25
00898302140438Clever Choice Comfort EZ"Insulin Syringe 27G 1cc 1/2"""98302-0140-432025-11-25
10898302140435Clever Choice Comfort EZInsulin Syringe 27G 1cc 1/2"98302-0140-432025-11-25
00898302140193Clever ChoiceFace Mask2022-01-04
00898302001890Clever ChoiceOrthopedic Back Brace2018-09-27
00898302001975Pharmacist ChoiceAlcohol Prep Pad 100ct62379-005-062016-08-01
00850002860382Clever Choice Peak Flow MeterSDI-PFM50002-0860-382019-11-04
00898302001456Clever ChoiceWhisper Aire Pediatric Child Nebulizer2017-01-02
00898302001449Clever ChoiceWhisper Aire Nebulizer2017-01-02
00898302140698Clever ChoiceSDI-BPMCA98302-0140-692023-02-14
00898302014180Clever ChoiceSDI-1486A BPM98302-0014-182023-02-13
00898302140124Clever ChoiceSDI-1796 BPM98302-0140-122022-06-07
00898302001005Simple DiagnosticsLAND98302-0001-002020-09-01
00898302001043Pharmacist ChoiceLAN3098302-0001-042020-09-01
00898302001609Pharmacist ChoiceLAN3198302-0001-602020-09-01
00898302140711Pharmacist ChoiceLAN3398302-0140-712020-09-02
00850002860603Pharmacist ChoiceULT3150002-0860-602022-10-19
00898302140209Comfort EZ Safety LancetCLES1002898302-0140-202022-10-19
10850002860600Pharmacist ChoiceULT3150002-0860-602022-10-19
20898302140203Comfort EZ Safety LancetCLES1002898302-0140-202022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
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