DEVICE: BiCart (07332414088316)

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Device Identifier (DI) Information

BiCart
720
109733
GAMBRO AB
07332414088316
GS1
1
Sodium Bicarbonate for Hemodialysis
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haemodialysis concentrate A 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.
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FDA Product Code

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Product Code Product Code Name
KPO DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 104 Degrees Fahrenheit
Storage Environment Temperature: less than 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 720 Gram
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Device Status

In Commercial Distribution
September 24, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
37332414088317 10 07332414088316 In Commercial Distribution CASE
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)933-0303
Medinfo_medproducts@baxter.com
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