FDA.reportPublic FDA data

COEfficient™

Primary DI
04046964334504
Brand
COEfficient™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
611235
Catalog number
611235
Device description
COE140 COEFFICIENT BALLOON 5 X 4 X 135
Published
2016-08-09
Public version status
Update
Distribution status
Not 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
MADCATHETER, PERCUTANEOUS (VALVULOPLASTY)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MADCatheter, Percutaneous (Valvuloplasty)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014124000NUMED COEFFICIENT PTV CATHETERSNuMED, Inc.2002-01-16OMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964334504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964334504040469643345044046964334504

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309823Micro-Access Elite®6133416133412016-08-09
04046964309847Micro-Access Elite®6133426133422016-08-09
04046964309861Micro-Access Elite®6133436133432016-08-09
04046964309885Micro-Access Elite®6133446133442016-08-09
04046964309908Micro-Access Elite®6133456133452016-08-09
04046964309922Micro-Access Elite®6133466133462016-08-09
04046964309946Micro-Access Elite®6133476133472016-08-09
04046964309960Micro-Access Elite®6133486133482016-08-09
04046964309977Micro-Access Elite®6133496133492016-08-09
04046964310003Micro-Access Elite®6133506133502016-08-09
04046964310027Micro-Access Elite®6133516133512016-08-09
04046964310041Micro-Access Elite®6133526133522016-08-09
04046964310065Micro-Access Elite®6133536133532016-08-09
04046964310089Micro-Access Elite®6133546133542016-08-09
04046964310102Micro-Access Elite®6133556133552016-08-09
04046964310126Micro-Access Elite®6133566133562016-08-09
04046964310140Micro-Access Elite®6133576133572016-08-09
04046964310164Micro-Access Elite®6133586133582016-08-09
04046964310188Micro-Access Elite®6133596133592016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046964333835COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333859COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333873COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333880COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333903COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333934COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333941COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333965COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964333996COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334016COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334023COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334047COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334078COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334085COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334108COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334122COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334153COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334160COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334184COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334207COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334221COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334245COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334269COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334283COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334306COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334320COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334344COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334368COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334375COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09
04046964334405COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09