Sol-Cart B® 802

GUDID 04046963332709

Solcart B® Bicarbonate Cartridge 650 grams

B.Braun Avitum AG

Haemodialysis concentrate
Primary Device ID04046963332709
NIH Device Record Keye9468e26-bf53-41c5-970e-cfe0ba73687a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSol-Cart B®
Version Model Number802
Catalog Number802
Company DUNS343689704
Company NameB.Braun Avitum AG
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com

Device Dimensions

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
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104046963332693 [Unit of Use]
GS104046963332709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2020-03-11
Device Publish Date2015-08-09

On-Brand Devices [Sol-Cart B®]

04046963621599Solcart B® Bicarbonate Cartridge 1100 grams
04046963332730Solcart B® Bicarbonate Cartridge 760 grams
04046963332709Solcart B® Bicarbonate Cartridge 650 grams

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.