FDA.reportPublic FDA data

Diabetic Specialty Solutions

Primary DI
00025715669908
Brand
Diabetic Specialty Solutions
Company
APOTHECARY PRODUCTS, LLC
Model
66990
Device description
TEMP PH TEST PAPER PPK 6/72
Published
2020-09-10
Public version status
New
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
CENDye-Indicator, Ph (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10025715669905PackageGS112In Commercial Distribution
20025715669902PackageGS16In Commercial Distribution
00025715669908PrimaryGS10
40025715232858Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002571566990510025715669905
2002571566990220025715669902
00025715669908000257156699080257156699080025715669908
4002571523285840025715232858

GMDN Terms#

Term, Definition table
TermDefinition
Urine test strip colour chart IVDA device in the form of a printed chart designed for the qualitative and semi-quantitative assessment of urine analyte (e.g., ketones, glucose, nitrites, leukocytes) concentration/pH by visually comparing urine test strip colour with a standard scale of colour variations that correlate with urine analyte concentration/pH. It is typically used to screen paediatric urine by clinicians in a healthcare facility or by laypersons in the home. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
092312735
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00025715688404Flents68840/HK688402020-10-28
00079573101988Acu-Life (HE)400198/400198A/HK400198/HK400198A2020-07-31
00079573108512CORE VALUES4008512020-08-31
00031046605065Ezy Dose Self-Care69797/697982021-03-26
00079573104361Acu-Life (HE)400436/400436A2020-09-10
00023185056051FLENTSF405-6052019-01-09
00025715010441FLENTSF405-6042016-09-06
00041520874825Care OneF405-605CO12019-01-09
00023185006032FLENTSF405-6032016-09-06
00025715673585FLENTS673582016-09-06
00025715848150FLENTS848152016-09-06
10025715673582FLENTS673582016-09-06
10025715848157FLENTS848152016-09-06
00023185056204FLENTSF405-6202016-09-06
00025715669502Diabetic Specialty Solutions66949/66949AZ2020-09-10
00025715690025FLENTS654002016-09-06
00840986020131CDCF405-620CD2017-03-06
00681131161756Walmart69002WM2017-01-20
00025715014401EZY DOSE71091BLAMT2022-08-01
00025715014432EZY DOSE71091GAMT2022-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.CEN2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.CEN2026-06-03
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983180600Alltest Multi-Drug 13 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983180617Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983181270Alltest Multi-Drug 9 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983186077Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14