Areta pH Urinalysis Reagent Strips (100 tests kit)

GUDID 00850253007024

EASY HEALTHCARE CORPORATION

Urine pH IVD, kit, colorimetric dipstick, rapid
Primary Device ID00850253007024
NIH Device Record Keyfd3a8877-a845-494a-b434-75deefc15cf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta pH Urinalysis Reagent Strips (100 tests kit)
Version Model NumberU031-013
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007024 [Primary]
GS100850253007031 [Package]
Package: [1 Units]
In Commercial Distribution
GS110850253007038 [Package]
Contains: 00850253007031
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-22
Device Publish Date2016-08-05

Devices Manufactured by EASY HEALTHCARE CORPORATION

10810038638154 - Easy@Home Blood Pressure Monitor 2025-08-08
10810038638857 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638874 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638881 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638898 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638904 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638928 - Premom Smart Basal Thermometer2025-08-08
00810038638935 - Easy@Home Digital Thermometer2025-08-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.