FDA.reportPublic FDA data

Vacuum Relief Check Valve

Primary DI
00803622123412
Brand
Vacuum Relief Check Valve
Company
LIVANOVA USA, INC.
Model
Vacuum Relief Check Valve
Published
2015-05-01
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

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
K982406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982406000COBE VACUUM RELIEF CHECK VALVECobe Cardiovascular, Inc.1998-10-07MJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622123419PackageGS120In Commercial Distribution
00803622123412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362212341910803622123419
00803622123412008036221234128036221234120803622123412

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous/external shunt connectorA device designed to connect an arteriovenous (AV) or external shunt to the tubing of an extracorporeal blood circuit, typically part of a haemodialysis system, for withdrawal/infusion of blood. It is typically made of plastic or metal and Y-shaped, allowing alternate withdrawal and infusion of blood. The device is intended to perform haemodialysis using the single-needle/single-lumen needle technique. This is a single-use device.

Regulatory Flags#

DUNS number
080914995
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622163715Perfusion PackPerfusion Pack2026-06-08
00803622163722Perfusion PackPerfusion Pack2026-06-08
00803622163586Perfusion PackPerfusion Pack2026-05-27
00803622163593Perfusion PackPerfusion Pack2026-05-27
00803622163616Perfusion PackPerfusion Pack2026-05-27
00803622163654Perfusion PackPerfusion Pack2026-05-27
00803622163678Perfusion PackPerfusion Pack2026-05-27
00803622163685Perfusion PackPerfusion Pack2026-05-27
00803622163746Perfusion PackPerfusion Pack2026-05-27
00803622163456Perfusion PackPerfusion Pack2026-05-18
00803622163463Perfusion PackPerfusion Pack2026-05-18
00803622163470Perfusion PackPerfusion Pack2026-05-18
00803622163500Perfusion PackPerfusion Pack2026-05-18
00803622163531Perfusion PackPerfusion Pack2026-05-18
00803622163555Perfusion PackPerfusion Pack2026-05-18
00803622163562Perfusion PackPerfusion Pack2026-05-18
00803622163579Perfusion PackPerfusion Pack2026-05-18
00803622163739Perfusion PackPerfusion Pack2026-05-18
00803622128370Tubing OrganizerAX-xxxxx2015-09-22
00803622161506Perfusion PackPerfusion Pack2026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10634624481005MiniGuard Arterial Safety ValveQUEST MEDICAL INCMJJ2019-01-18
10634624482002MiniGuard Arterial Safety Valve, Non-SterileQUEST 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
10803622123419Vacuum Relief Check ValveLIVANOVA USA, INC.MJJ2015-05-01