B.BRAUN 7105232

GUDID 04046964057434

Patient Therapy Card (7105232)

B.Braun Avitum AG

Haemodialysis system, institutional
Primary Device ID04046964057434
NIH Device Record Key24bb4dee-de28-4de3-9233-66f0b62ee9dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameB.BRAUN
Version Model Number7105232
Catalog Number7105232
Company DUNS343689704
Company NameB.Braun Avitum AG
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)848-2066
Emailrtd.us@bbraun.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964057434 [Primary]
GS104046964453045 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2020-04-09
Device Publish Date2015-08-09

On-Brand Devices [B.BRAUN]

04046964966149ABPM CUFF, EXTRA LARGE, LATEX FREE (XL)
04046964762734OPTION STAFF CALL SW9.XX
04046964738388CCS CONNECTOR FOR 3 CONCENTRATES
04046964337017The Plasmat® Futura Sy stem
04046964319860H.E.L.P. Heparin Sodium Solution 30 mL
04046964290169HELP ACETATE BUFFER 4.85 US 3000ML
04046964290152HELP BIC EL HCL US 5000ML
04046964290145HELP 0,9 % SODIUM CHLORIDE US 3000ML
04046964290138HELP 0,9 % SODIUM CHL. SET US 500/1500ML
04046963711184EMPTY BAGS FOR DIALYSATE FUTURA (US)
04046964231834HELP HEPARIN ADSORBER 400 US/CA
04046964133534HELP FUTURA SET WITH 4 FILTERS (US)
04046964091827OPTION ADIMEA
04046964091728Adimea™ Dialysis Measurement Sy stem (Kt/V) for Dialog+®
04046964057434Patient Therapy Card (7105232)
04046963847418EMPTY BAG CONNECTION LINE (US)
04046963845797H.E.L.P. HEMOSELECT L 0,5
04046963845780H.E.L.P. HEPARIN ADSORBER (US)
04046963845773H.E.L.P. ULTRAFILTER SMC 1.8 (US)
04046963845766H.E.L.P. PRECIPITATE FILTER (US)
04046963816605Dialog+® Patient Thera py Card Reader
04046963711177EMPTY BAG FOR PRIMING SOLUTION FUTURA US
04046963711160DIALYSING LINE FUTURA (US)
04046963711153ARTERIAL LINE FUTURA (US)
04046963711139H.E.L.P.® Plasmat ® Futura Treatment Kit
04046963686772OPTION 7X10 ROLLER FOR BLOODPUMP SW9.XX
04046963686758Option WAN BSL Dialog+ SW 9 (7102231)
04046963686734Option Nexadia BSL SW 9.xx (7102230)
04046963686727Dialog+® UltraPure Flu id Hemodialysis System Filter Kit
04046963686710OPTION ACCU DIALOG + SW9.XX
04046963686697Dialog+® Hemodialysis System Bicarbonate Cartridge Holder (BIC)
04046963686680OPTION ABPM DIALOG+ SW9.XX
04039239070474Emergency (standby) power supply (710524 4)
04039239070467ABPM (7105226)
04039239070450Central concentrate supply (7105196)
04039239070443Bicarbonate cartridge (7105170)
04039239070436Dialysis fluid filter (7105102)
04039239041733DCI CABLE
04039239040859ABPM Cuff (medium) (7102771)
04039239040743ABPM Cuff (large) (7102380)
04039239040729ABPM Cuff (small) (7102372)

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