FDA.reportPublic FDA data

Diacap®

Primary DI
04046963178116
Brand
Diacap®
Company
B.Braun Avitum AG
Model
7107368
Catalog number
7107368
Device description
DIACAP ULTRA DF FILTER CA & US
Published
2022-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKQSystem, dialysate delivery, central multiple patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKQSystem, Dialysate Delivery, Central Multiple PatientGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963178116PrimaryGS10
04046963178109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963178116040469631781164046963178116
04046963178109040469631781094046963178109

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system dialysate pyrogen filterA sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)848-2066rtd.us@bbraun.com

Regulatory Flags#

DUNS number
343689704
Device count
6
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
04046963178109Diacap®B.Braun Avitum AGFKQ2022-11-21
40677964016729Actril Cold SterilantMEDIVATORS INC.FKQ2020-03-24
40677964016736Actril Cold SterilantMEDIVATORS INC.FKQ2020-03-24
10677964105972Actril Indicator Test StripsMEDIVATORS INC.FKQ2018-12-04
00677964082214Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2018-07-13
40677964023987Actril Residual Test StripsMEDIVATORS INC.FKQ2018-07-09
10677964008259Actril Residual Test StripsMEDIVATORS INC.FKQ2018-07-09
10677964009119Perassay 500 Peracetic Acid Test StripsMEDIVATORS INC.FKQ2018-07-09
00677964091766Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2018-06-15
30677964091767Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2018-06-15
00677964000249Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
00677964000294Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
30677964000240Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
30677964000295Actril Cold SterilantMEDIVATORS INC.FKQ2018-02-26
00677964044281Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-21
00677964000300Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000317Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000324Centrisol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000331Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000348Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000355Renasol Bicarbonate Concentrate PowderMEDIVATORS INC.FKQ2016-09-20
00677964000393Renasol Liquid Bicarbonate ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000409Centrisol Liquid Bicarbonate ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000485Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000492Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000508Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000515Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000522Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000539Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20
00677964000546Centrisol Acid ConcentrateMEDIVATORS INC.FKQ2016-09-20