AccessGUDID - DEVICE: MAQUET CARDIOHELP (04037691658384)

GUDID

Device Identifier (DI) Information

Brand Name: MAQUET CARDIOHELP
Version or Model: CARDIOHELP System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70104.8012
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691658384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: Cardiohelp-i

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:	Yes
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?
35099	Cardiopulmonary bypass system, roller type	An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.	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 [?]
K133598	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: f599346c-a521-4cad-b8d9-8f52bc9c9838
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 06, 2015