AccessGUDID - DEVICE: Terumo® Advanced Perfusion System 1 (00886799000540)

GUDID

Device Identifier (DI) Information

Brand Name: Terumo® Advanced Perfusion System 1
Version or Model: 801041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 801041
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799000540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: Roller Pump (6" Blue). The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36347	Cardiopulmonary bypass system roller pump	A mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151349	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2824c68-e26a-4fcd-a9fb-2ae6f7b1fb04
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015