FDA.reportPublic FDA data

B.BRAUN

Primary DI
04046964290152
Brand
B.BRAUN
Company
B.Braun Avitum AG
Model
4109
Catalog number
4109
Device description
HELP BIC EL HCL US 5000ML
Published
2017-01-18
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
MMYLIPOPROTEIN, LOW DENSITY, REMOVAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P940016000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964290152PrimaryGS10
04046964041600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964290152040469642901524046964290152
04046964041600040469640416004046964041600

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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)848-2066rtd.us@bbraun.com

Regulatory Flags#

DUNS number
343689704
Device count
2
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
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
04046964699467H.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