FDA.reportPublic FDA data

MPS Back Up System, side crank

Primary DI
20634624510153
Brand
MPS Back Up System, side crank
Company
QUEST MEDICAL INC
Model
5001015
Device description
MPS Back Up System, side crank, blood only.
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002366000QUEST MPS BACK-UP SYSYEMQuest Medical, Inc.2000-09-18DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624510153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462451015320634624510153

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heat exchanger, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-627-0226Custserv@questmedical.com

Regulatory Flags#

DUNS number
041810693
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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