Primary Device ID | 10885325001423 |
NIH Device Record Key | a5c4dd2d-ec41-41eb-8cbe-b5f31877c498 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tempo |
Version Model Number | 343105 |
Company DUNS | 688840958 |
Company Name | i-SENS, Inc. |
Device Count | 100 |
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 | true |
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 |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885325001426 [Primary] |
GS1 | 10885325001423 [Package] Contains: 00885325001426 Package: Case Pack [35 Units] In Commercial Distribution |
GS1 | 20885325001420 [Package] Package: Master Case Carton [10 Units] In Commercial Distribution |
GS1 | 50885325001414 [Unit of Use] |
CGA | Glucose Oxidase, Glucose |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-25 |
Device Publish Date | 2021-02-17 |
10885325001423 | Tempo Blood Glucose Test Strip |
10885325001416 | Tempo Blood Glucose Test Strip |
10885325001409 | Tempo Blood Glucose Monitoring System |
10885325001386 | Tempo Blood Glucose Monitoring System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TEMPO 98752518 not registered Live/Pending |
Responsive Environments Inc. 2024-09-16 |
TEMPO 98740633 not registered Live/Pending |
Eli Lilly and Company 2024-09-09 |
TEMPO 98687902 not registered Live/Pending |
McBarnette Neilley, Cathy L 2024-08-07 |
TEMPO 98467788 not registered Live/Pending |
TEMPO ORGAN PROCUREMENT PROFESSIONALS, LLC 2024-03-26 |
TEMPO 98460502 not registered Live/Pending |
Pace Surgical, Inc. 2024-03-21 |
TEMPO 98438084 not registered Live/Pending |
GHP Group, Inc. 2024-03-07 |
TEMPO 98346854 not registered Live/Pending |
Ergodriven Inc 2024-01-08 |
TEMPO 98272495 not registered Live/Pending |
Capital One Financial Corporation 2023-11-15 |
TEMPO 98258052 not registered Live/Pending |
AVY Entertainment, Inc. 2023-11-07 |
TEMPO 98258051 not registered Live/Pending |
AVY Entertainment, Inc. 2023-11-07 |
TEMPO 98258047 not registered Live/Pending |
AVY Entertainment, Inc. 2023-11-07 |
TEMPO 98258043 not registered Live/Pending |
AVY Entertainment, Inc. 2023-11-07 |