autoLog IQ™
GUDID 00643169982864
SYSTEM ATLGIQ AUTOTRANSFUSION US
MEDTRONIC, INC.
Blood-processing autotransfusion system set Blood-processing autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set| Primary Device ID | 00643169982864 |
| NIH Device Record Key | cf3522ff-f93a-4750-8d18-34f582d13387 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | autoLog IQ™ |
| Version Model Number | ATLGIQ |
| 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. |
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169982864 [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 |
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