VeraSens Voice

GUDID 10857513006190

VeraSens Voice Blood Glucose Meter

i-SENS, Inc.

Home-use/point-of-care glucose analyser IVD, battery-powered
Primary Device ID10857513006190
NIH Device Record Keybbac72ae-767c-4139-aafb-23e67f880332
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraSens Voice
Version Model Number282442
Company DUNS688840958
Company Namei-SENS, Inc.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone866-216-5308
Emailjkupar@usdiagnostics.net

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100857513006193 [Primary]
GS110857513006190 [Package]
Contains: 00857513006193
Package: Master Case Carton [70 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2016-09-23

On-Brand Devices [VeraSens Voice]

20857513006203VeraSens Voice Blood Glucose Test Strip
10857513006190VeraSens Voice Blood Glucose Meter

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