AccessGUDID - DEVICE: PLEGIOX Cardioplegia Heat Exchanger (04037691229591)

GUDID

Device Identifier (DI) Information

Brand Name: PLEGIOX Cardioplegia Heat Exchanger
Version or Model: BO-CHX 30, SOFTLINE, Sterile
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70103.4981
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691229591
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
11973	Cardiopulmonary bypass system heat exchanger, reusable	A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTZ	Oxygenator, Cardiopulmonary Bypass
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
DTR	Heat-Exchanger, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112360	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: c137f443-d2ae-4ef6-bc98-e6f0a982d3af
Public Version Date: September 30, 2024
Public Version Number: 5
DI Record Publish Date: March 13, 2017