On Call Diabetes Management Software

GUDID 00682607001118

Home-use/point-of-care blood glucose monitoring system IVD

Primary Device ID	00682607001118
NIH Device Record Key	95e056e9-5afd-46e2-a5b8-0abd7e389d46
Commercial Distribution Status	In Commercial Distribution
Brand Name	On Call Diabetes Management Software
Version Model Number	1.2.89
Company DUNS	781100966
Company Name	ACON LABORATORIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00682607001118 [Primary]

JQP	CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Steralize Prior To Use	false
Device Is Sterile	false

20682607200485 - Mission U120 Smart Urine Analyzer	2026-02-16 URINE ANALYZER
20682607200492 - Mission U120 Smart Urine Analyzer	2026-02-16 URINE ANALYZER with Barcode Reader
20682607200904 - Mission U120 Touch Urine Analyzer	2026-02-16 URINE ANALYZER
20682607200911 - Mission U120 Touch Urine Analyzer	2026-02-16 URINE ANALYZER with Barcode Reader
20682607541823 - On Call Stealth Lancing Device	2026-02-11 1 Lancing Device
00810107290033 - Flowflex Plus COVID-19 + Flu A/B Home Test	2026-02-09 1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cas
20682607660265 - Flowflex COVID-19 Antigen Home Test	2026-02-03 1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cas
20810107290143 - Flowflex Plus Strep A Rapid Test Cassette	2025-12-09 25 Test per kit (L03A-R0115):Test Cassettes (25), Test Tubes (25), Dropper Tips (25), Throat Swabs (25), Reagent A (1), Reagent