KetoSens

GUDID 10885325000853

KetoSens B-Ketone Monitoring System with Lancets

i-SENS, Inc.

Multiple clinical chemistry analyte monitoring system IVD, home-use
Primary Device ID10885325000853
NIH Device Record Keyb5ce0c86-49b9-42d5-baef-82082b3de81f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKetoSens
Version Model Number276261-201
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com
Phone1-800-429-5001
Emailcs1@i-sens.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100885325000856 [Primary]
GS110885325000853 [Package]
Contains: 00885325000856
Package: Master Case Carton [70 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-03
Device Publish Date2020-11-10

On-Brand Devices [KetoSens]

10885325001492KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)
10885325000853KetoSens B-Ketone Monitoring System with Lancets

Trademark Results [KetoSens]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KETOSENS
KETOSENS
88385084 not registered Live/Pending
I-SENS, INC.
2019-04-14
KETOSENS
KETOSENS
79386773 not registered Live/Pending
I-sens, Inc.
2023-08-30
KETOSENS
KETOSENS
79225969 5609145 Live/Registered
I-SENS, INC.
2017-12-06
KETOSENS
KETOSENS
79225951 5609144 Live/Registered
I-SENS, INC.
2017-12-06

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