Primary Device ID | 00763000057480 |
NIH Device Record Key | b6e3bca2-f346-4b96-ae3b-518e8f074d7a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | autoLog IQ™ |
Version Model Number | ATLGIQE |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
Serial Number | true |
Manufacturing Date | false |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000057480 [Primary] |
CAC | APPARATUS, AUTOTRANSFUSION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-12 |
Device Publish Date | 2018-09-11 |
00643169982864 | SYSTEM ATLGIQ AUTOTRANSFUSION US |
00763000057503 | SYSTEM ATLGIQR AUTOLOG AUTOTRANS RECOND |
00763000057480 | SYSTEM ATLGIQE AUTOLOG AUTOTRANS EVAL |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUTOLOG IQ 90100280 not registered Live/Pending |
Medtronic, Inc. 2020-08-07 |
AUTOLOG IQ 87218289 not registered Live/Pending |
Medtronic, Inc. 2016-10-27 |