DEVICE: DIASOL (B46710042575100)
Device Identifier (DI) Information
DIASOL
100425-75100
In Commercial Distribution
ACD35-ACG73
DIASOL, INC.
100425-75100
In Commercial Distribution
ACD35-ACG73
DIASOL, INC.
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35849 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K851431 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep from freezing and excessive heat. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
73a58cd7-34bf-4ca4-887a-fb067c05c4da
July 06, 2018
3
February 13, 2017
July 06, 2018
3
February 13, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B4671004257510055 | 1 | B46710042575100 | In Commercial Distribution | DRUM | |
B467100425751004 | 4 | B46710042575100 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
818-838-7077
Diasolinc@gmail.com
Diasolinc@gmail.com