AccessGUDID - DEVICE: Maquet HL-20 System (04037691224510)

GUDID

Device Identifier (DI) Information

Brand Name: Maquet HL-20 System
Version or Model: AEP 20-415 Bubble Level Monitoring Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70101.0853
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691224510
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is an accessory for The Heart-Lung Machine HL 20 , which is a modular system for regulation, control and monitoring of the extracorporeal circulation. Its purpose is the support and maintenance of the extracorporeal blood circulation and is used during cardiac surgeries.

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: 28.215 Liter
Weight: 4220 Gram

Device Record Status

Public Device Record Key: 3167bc60-6953-4899-a3ea-09d9db6f970d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 13, 2017