Primary Device ID | 10885325000853 |
NIH Device Record Key | b5ce0c86-49b9-42d5-baef-82082b3de81f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KetoSens |
Version Model Number | 276261-201 |
Company DUNS | 688840958 |
Company Name | i-SENS, 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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com | |
Phone | 1-800-429-5001 |
cs1@i-sens.com |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885325000856 [Primary] |
GS1 | 10885325000853 [Package] Contains: 00885325000856 Package: Master Case Carton [70 Units] In Commercial Distribution |
JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-08-03 |
Device Publish Date | 2020-11-10 |
10885325001492 | KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) |
10885325000853 | KetoSens B-Ketone Monitoring System with Lancets |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KETOSENS 88385084 not registered Live/Pending |
I-SENS, INC. 2019-04-14 |
KETOSENS 79386773 not registered Live/Pending |
I-sens, Inc. 2023-08-30 |
KETOSENS 79225969 5609145 Live/Registered |
I-SENS, INC. 2017-12-06 |
KETOSENS 79225951 5609144 Live/Registered |
I-SENS, INC. 2017-12-06 |