MPS Hypothermic Reservoir Holder

Basic Information

• Brand Name: MPS Hypothermic Reservoir Holder
• Primary DI: 20634624510023
• Version / Model: 5001002
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-10
• Public Version: 2
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 5f41500c-5de6-46f5-8c17-970f2cf3cbcc

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	870.4240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20634624510023	GS1

Premarket Submissions

Submission Number	Supplement Number
K953838	000