FDA.reportPublic FDA data

Diabetic Specialty Solutions

Primary DI
20025715669902
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
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
092312735
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00025715014449EZY DOSE71091PAMT2022-08-01
00025715014593EZY DOSE68259BLAMT2022-08-01
00025715014609EZY DOSE68259GAMT2022-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16936983187074Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187081Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187098Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187104Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187135Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187142Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187159Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187166Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187173Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187180Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187203Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187210Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16942598222673Alltest Multi-Drug 18 Drugs Urine Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14