FDA.reportPublic FDA data

MPS 3 Delivery Set w/183cm (16C)

Primary DI
00634624500358
Brand
MPS 3 Delivery Set w/183cm (16C)
Company
QUEST MEDICAL INC
Model
5163100
Published
2020-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
20634624500352PackageGS110In Commercial Distribution
00634624500358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462450035220634624500352
00634624500358006346245003586346245003580634624500358

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration kitA collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
041810693
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10634624100616Tie-V Securement DeviceQIVB00602022-12-15
00634624417021Lyka® PORT Needle Free Access Device4170Y2025-06-12
20634624533039Vessel Cannula, 3mmVCC-03VCC-032016-06-07
00634624031500Q2® Needleless injection site 315031502017-03-09
20634624100606Qlinch Securement BandQSB00602020-04-08
20634624530380MPS 3 ISO Medical Air Hose Kit5303010-CA2023-10-16
00634624096523Checkmate IV Administration Set 123in (312 cm)965296522016-07-29
20634624530397MPS 3 Drug Pump Cover53030312023-03-24
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624911048High-Flow Extension SetHF01352022-12-12
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624921092High-Flow 4-Way StopcockSTV022022-12-06
00634624921108High-Flow 4-Way StopcockSTV032022-12-06
00634624921160High-Flow 4-Way StopcockST012022-12-06
00634624921191High-Flow 4-Way StopcockST032022-12-06
00634624921207Q2 Blood Administration SetYV1152022-12-06
00634624921214Q2 Blood Administration SetYV1302022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08033178112840KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTR2024-03-20