Terumo® Advanced Perfusion System 1

Basic Information

• Brand Name: Terumo® Advanced Perfusion System 1
• Primary DI: 00886799001820
• Version / Model: 90000746
• Catalog Number: 90000746
• Company Name: Terumo Cardiovascular Systems Corporation
• Labeler DUNS: 177655466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-24
• Public Version: 1
• Public Version Date: 2023-06-01
• Public Version Status: New
• Public Device Record Key: ab0d64cd-ae79-4588-9814-d1a93a57350e

Device Description

The mounting arm attaches to the APS1 vertically mounting pole and is used as a mount for the Central Control Monitor.

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	870.4220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61434	Portable active medical device mount	A device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886799001820	GS1

Premarket Submissions

Submission Number	Supplement Number
K221895	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit