autoLog IQ™

Basic Information

• Brand Name: autoLog IQ™
• Primary DI: 00763000057503
• Version / Model: ATLGIQR
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-11
• Public Version: 2
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 6b7cdd23-140d-4def-a00d-a66b9fee31bf

Device Description

SYSTEM ATLGIQR AUTOLOG AUTOTRANS RECOND

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAC	APPARATUS, AUTOTRANSFUSION	Anesthesiology	868.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34863	Red blood cell-recovery autotransfusion system	An assembly of devices designed to collect and process blood lost by a patient to obtain red blood cells for subsequent reinfusion into the same patient (i.e., autotransfusion). It typically includes a disposable suction system to collect blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., a centrifuge) to separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate microfilters, and a reinfusion bag that stores the red blood cells in saline. The system is used mainly during surgical procedures to minimize allogeneic blood use, but may be used postoperatively and in emergency or intensive care units.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000057503	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181954	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 59.5 – 101 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Store the device in a cool, dry, and well-ventilated area.