On Call Vivid Blood Glucose Monitoring System

GUDID 00682607000012

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

ACON LABORATORIES, INC.

Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD
Primary Device ID00682607000012
NIH Device Record Key0816fbb7-12df-4d2e-82f0-4e83ae23bff8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn Call Vivid Blood Glucose Monitoring System
Version Model NumberG115-102
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000012 [Direct Marking]
GS100682607556113 [Primary]
GS100682607556151 [Primary]
GS100682607571017 [Primary]
GS100682607571024 [Primary]
GS110682607556110 [Package]
Contains: 00682607556113
Package: case [4 Units]
In Commercial Distribution
GS110682607556158 [Package]
Contains: 00682607556151
Package: case [4 Units]
In Commercial Distribution
GS110682607571014 [Package]
Contains: 00682607571017
Package: Case [4 Units]
In Commercial Distribution
GS110682607571021 [Package]
Contains: 00682607571024
Package: Case [4 Units]
In Commercial Distribution
GS120682607556117 [Package]
Contains: 10682607556110
Package: carton [6 Units]
In Commercial Distribution
GS120682607556155 [Package]
Contains: 10682607556158
Package: carton [6 Units]
In Commercial Distribution
GS120682607571011 [Package]
Contains: 10682607571014
Package: Carton [6 Units]
In Commercial Distribution
GS120682607571028 [Package]
Contains: 10682607571021
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ACON LABORATORIES, INC.

10682607630308 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
10682607630544 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
20682607630558 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
20682607651256 - HealthyMe UTI Urinary Tract Infection Test Strips2024-04-04 Urinary Tract Infection home test with handle
20682607200508 - MISSION U500 URINE ANALYZER2024-03-18 URINE ANALYZER
20682607200515 - MISSION U500 URINE ANALYZER2024-03-18 URINE ANALYZER with Barcode Reader
20682607660272 - Flowflex COVID-19 Antigen Home Test2021-11-30 Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
20682607660289 - Flowflex COVID-19 Antigen Home Test2021-11-30 Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.