FDA.reportPublic FDA data

Vacuum Relief Check Valve

Primary DI
10803622123419
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00803622123412Vacuum Relief Check ValveLIVANOVA USA, INC.MJJ2015-05-01