FDA.reportPublic FDA data

H.E.L.P.®

Primary DI
04046964699467
Brand
H.E.L.P.®
Company
B.Braun Avitum AG
Model
7061192
Catalog number
7061192
Device description
HELP HEPARIN 400,000 IU V 50/40ML US
Published
2016-03-09
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
MMYLIPOPROTEIN, LOW DENSITY, REMOVAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMYLipoprotein, Low Density, RemovalUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P940016000
P940016016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P940016000H.E.L.P. SYSTEMB. Braun Avitum AG1997-09-19MMY
P940016016H.E.L.P. SYSTEMB. Braun Avitum AG1997-09-19MMY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964699467PrimaryGS10
04046955348367Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964699467040469646994674046964699467
04046955348367040469553483674046955348367

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis kitA collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
343689704
Device count
80
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964285608Dialog+®710200S710200S2015-08-09
04046955725151AQUAbase®LA1101326LA11013262023-10-09
04046955725168AQUAbase®LA1101351LA11013512023-10-09
04046955725175AQUAbase®LA1101376LA11013762023-10-09
04046955659623Diacap®720DH13G720DH13G2022-09-16
04046955659647Diacap®720DH16G720DH16G2022-09-16
04046955659661Diacap®720DH19G720DH19G2022-09-16
04039239040729B.BRAUN710237271023722017-10-28
04039239040743B.BRAUN710238071023802017-10-28
04039239040859B.BRAUN710277171027712015-08-09
04046964966149B.BRAUN710239071023902017-10-28
04046955659616Diacap®720DH13G720DH13G2022-09-16
04046955659630Diacap®720DH16G720DH16G2022-09-16
04046955659654Diacap®720DH19G720DH19G2022-09-16
04039239090496Diacap®710736771073672015-08-09
04046963845766B.BRAUN721093172109312017-01-18
04046964231834B.BRAUN721108972110892017-01-18
04046964696770H.E.L.P.®721110172111012016-03-09
04046963686338Dialog+®710200K710200K2015-08-09
04046963686345Dialog+®710200L710200L2015-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18855036020688TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCMMY2018-08-21
04046963711139B.BRAUNB.Braun Avitum AGMMY2017-01-20
04046963845773B.BRAUNB.Braun Avitum AGMMY2017-01-20
04046964249679B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711153B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711160B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711177B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845766B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845780B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963847418B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964133534B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964231834B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963711184B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290138B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290145B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290152B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964290169B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046964319860B.BRAUNB.Braun Avitum AGMMY2017-01-18
04046963845797B.BRAUNB.Braun Avitum AGMMY2017-01-17
04046964156731H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964695865H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
04046964696770H.E.L.P.®B.Braun Avitum AGMMY2016-03-09
18855036012850TUBING SYSTEM FOR PLASMAPHERESISKANEKA PHARMA AMERICA LLCMMY2015-02-09
04537693900639SULFLUXKANEKA PHARMA AMERICA LLCMMY2014-12-17
14993478010110LIPOSORBERKANEKA CORPORATIONMMY2014-09-26
04987671040374APHERESIS MACHINEKANEKA PHARMA AMERICA LLCMMY2014-09-25
04046964337017B.BRAUNB.Braun Avitum AGMMY2014-09-15