Sol-Cart B®

Primary DI
04046963621599
Brand
Sol-Cart B®
Company
B.Braun Avitum AG
Model
805
Catalog number
805
Device description
Solcart B® Bicarbonate Cartridge 1100 grams
Published
2015-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102194000SOLCART BB. Braun Avitum AG2011-04-25KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963621599PrimaryGS10
04046963621582Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963621599040469636215994046963621599
04046963621582040469636215824046963621582

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 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
8
Lot or batch
true
Expiration date on label
true

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04046964696770H.E.L.P.®721110172111012016-03-09
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04046963686345Dialog+®710200L710200L2015-08-09

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Primary DI, Brand, Company table
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