FDA.reportPublic FDA data

MPS 3 Power cord

Primary DI
20634624530168
Brand
MPS 3 Power cord
Company
QUEST MEDICAL INC
Model
530NA16
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTRHeat-Exchanger, Cardiopulmonary Bypass
DWCController, Temperature, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200438000MPS 3 Myocardial Protection SystemQuest Medical, Inc.2020-06-19DTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624530168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462453016820634624530168

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. 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
Primary DIBrandModelCatalogPublished
00634624530485MPS® 3 Console Pole Mount Plate530102453010242026-07-20
006346240906516" (15 cm) Microbore Extension Set with Clamp90652017-02-13
006346240925017 in (18cm) Y-Extension Set w/ 2 check valves925092502016-07-26
0063462409541044 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site954195412016-07-26
00634624095434Q2 Checkmate Extension Set95432016-06-10
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
00634624621039Precision Delivery IV Extension SetPDM602021-02-05
00634624621046Precision Delivery IV Extension SetPDM60F2021-02-05
00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621077Precision Delivery IV Extension SetPDV062021-02-05
00634624621084Precision Delivery IV Extension SetPDV06F2021-02-05
00634624621091Precision Delivery IV Extension SetPDV602021-02-05
00634624621107Precision Delivery IV Extension SetPDV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634624530485MPS® 3 Console Pole Mount PlateQUEST MEDICAL INCDTR2026-07-20
00634624530485MPS® 3 Console Pole Mount PlateQUEST MEDICAL INCDWC2026-07-20
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
00850054036254CardioQuip Dripless Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036261CardioQuip Dripless Hose Set 10' 90 Connectors and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036278CardioQuip Dripless Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036285CardioQuip Dripless Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036292CardioQuip Dripless Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036308CardioQuip Dripless Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036315CardioQuip Dripless End SetCARDIOQUIP, LLCDWC2025-10-27
00850054036322CardioQuip Dripless End Set with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036339"CardioQuip Oxygenator Connector, Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036346"CardioQuip Oxygenator Connector. Straight, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036353"CardioQuip Main/CPG Connector. Male. Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036360CardioQuip Standard Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036377CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036384CardioQuip Standard Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036391CardioQuip Standard Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036407CardioQuip Standard Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036414CardioQuip Standard Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036421CardioQuip Dripless Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036438CardioQuip Dripless Hose Set 6' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036445CardioQuip Standard Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036452CardioQuip Standard Hose Set 6' with Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036605CardioQuip Mini wheel SetCARDIOQUIP, LLCDWC2025-10-27