KetoSens
GUDID 10885325001492
KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10)
i-SENS, Inc.
Multiple clinical chemistry analyte monitoring system IVD, home-use| Primary Device ID | 10885325001492 |
| NIH Device Record Key | 3293d564-5a0b-466c-84e5-726b8c94546d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KetoSens |
| Version Model Number | 276265 |
| 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 | false |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885325001495 [Primary] |
| GS1 | 10885325001492 [Package] Contains: 00885325001495 Package: Master Case Carton [70 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201551
FDA Product Code
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-03 |
| Device Publish Date | 2020-11-10 |
On-Brand Devices [KetoSens]
| 10885325001492 | KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) |
| 10885325000853 | KetoSens B-Ketone Monitoring System with Lancets |
Trademark Results [KetoSens]
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.