AccessGUDID - DEVICE: MAQUET HL-20 System (04037691211190)

GUDID

Device Identifier (DI) Information

Brand Name: MAQUET HL-20 System
Version or Model: DTI 1/4"x1/16" (2 pcs)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70102.0804
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691211190
Issuing Agency: GS1
Commercial Distribution End Date: September 17, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.

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):	No
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?
35440	Cardiopulmonary bypass system air bubble/fluid level detector	A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.	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 [?]
K943803	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
Total Volume: 0.118 Liter

Device Record Status

Public Device Record Key: a34de4e0-40de-4bc7-9e98-afcd551417f3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 13, 2017