FDA.reportPublic FDA data

COEfficient™

Primary DI
04046964334283
Brand
COEfficient™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
611224
Catalog number
611224
Device description
COE124 COEFFICIENT BALL 11MM X 4CM
Published
2016-08-09
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
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
04046964334283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964334283040469643342834046964334283

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store at room temp

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
04046955642489Seamless™6147026147022023-06-29
04046955668823COMPASS ™6139446139442021-12-07
04046955668847COMPASS ™6139456139452021-12-07
04046955668861COMPASS ™6139466139462021-12-07
04046955668885COMPASS ™6139476139472021-12-07
04046955668908COMPASS ™6139486139482021-12-07
04046955668922COMPASS ™6139496139492021-12-07
04046955668946COMPASS ™6139506139502021-12-07
04046955668960COMPASS ™6139516139512021-12-07
04046955668984COMPASS ™6139526139522021-12-07
04046955669004COMPASS ™6139536139532021-12-07
04046955669028COMPASS ™6139546139542021-12-07
04046955669042COMPASS ™6139556139552021-12-07
04046955669066COMPASS ™6139566139562021-12-07
04046955669080COMPASS ™6139576139572021-12-07
04046955669103COMPASS ™6139586139582021-12-07
04046955669127COMPASS ™6139596139592021-12-07
04046955669141COMPASS ™6139606139602021-12-07
04046955669165COMPASS ™6139616139612021-12-07
04046955669189COMPASS ™6139626139622021-12-07

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
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
04046964334429COEfficient™B BRAUN INTERVENTIONAL SYSTEMS, INCMAD2016-08-09