autoLog IQ™
GUDID 00763000057503
SYSTEM ATLGIQR AUTOLOG AUTOTRANS RECOND
MEDTRONIC, INC.
Blood-processing autotransfusion system| Primary Device ID | 00763000057503 |
| NIH Device Record Key | 6b7cdd23-140d-4def-a00d-a66b9fee31bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | autoLog IQ™ |
| Version Model Number | ATLGIQR |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a cool, dry, and well-ventilated area. |
| Storage Environment Atmospheric Pressure | Between 59.5 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000057503 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181954
FDA Product Code
| CAC | APPARATUS, AUTOTRANSFUSION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-12 |
| Device Publish Date | 2018-09-11 |
On-Brand Devices [autoLog IQ™]
| 00643169982864 | SYSTEM ATLGIQ AUTOTRANSFUSION US |
| 00763000057503 | SYSTEM ATLGIQR AUTOLOG AUTOTRANS RECOND |
| 00763000057480 | SYSTEM ATLGIQE AUTOLOG AUTOTRANS EVAL |
Trademark Results [autoLog IQ]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.