Primary Device ID | 10884521821545 |
NIH Device Record Key | 919e1636-6bd1-4ad5-bcd1-be1369a0e136 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GI Genius |
Version Model Number | CB1708-RFB |
Company DUNS | 058614483 |
Company Name | Covidien LP |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10884521821545 [Primary] |
QNP | Gastrointesinal lesion software detection system |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-29 |
Device Publish Date | 2021-11-20 |
10884521807259 | Intelligent Endoscopy Module |
10884521821545 | Intelligent Endoscopy Module , Refurbished |
10884521844544 | GGI Genius (TM) System 200 |
10884521844537 | GGI Genius (TM) System 100 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GI GENIUS 88431147 not registered Live/Pending |
Covidien LP 2019-05-15 |