FDA.reportPublic FDA data

MiniGuard Arterial Safety Valve, Non-Sterile

Primary DI
10634624482002
Brand
MiniGuard Arterial Safety Valve, Non-Sterile
Company
QUEST MEDICAL INC
Model
4008200
Catalog number
4008200
Published
2019-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJJCpb Check Valve, Retrograde Flow, In-Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJJCpb Check Valve, Retrograde Flow, In-LineCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182442000MiniGuard Arterial Safety ValveQuest Medical, Inc.2018-11-06MJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624482009PackageGS15In Commercial Distribution
10634624482002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462448200920634624482009
1063462448200210634624482002

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system valve, unidirectional flow/pressure controlA sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device.

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
10634624481005MiniGuard Arterial Safety ValveQUEST MEDICAL INCMJJ2019-01-18
10634624472003RetroGuard Arterial Safety ValveQUEST MEDICAL INCMJJ2016-06-06
20634624472000RetroGuard Arterial Safety ValveQUEST MEDICAL INCMJJ2016-06-06
00634624471009RetroGuard Arterial Safety ValveQUEST MEDICAL INCMJJ2016-06-03
20634624471003RetroGuard Arterial Safety ValveQUEST MEDICAL INCMJJ2016-06-03
00803622123412Vacuum Relief Check ValveLIVANOVA USA, INC.MJJ2015-05-01
10803622123419Vacuum Relief Check ValveLIVANOVA USA, INC.MJJ2015-05-01