AccessGUDID - DEVICE: ACCUSOL Dialysis Solution for CRRT (09349285000192)

GUDID

Device Identifier (DI) Information

Brand Name: ACCUSOL Dialysis Solution for CRRT
Version or Model: 30 2K+ 0Ca++
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5B9252
Company Name: Nikkiso Belgium BVBA

Primary DI Number: 09349285000192
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 370482633 *Terms of Use

Device Description: Accusol 30 2K+ 0Ca++ Solution is indicated for use as dialysis solution in Continuous Renal Replacement Therapy.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.	Active	false

FDA Product Code

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Product Code	Product Code Name
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041428	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
Storage Environment Temperature: less than 25 Degrees Celsius
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2500 Milliliter

Device Record Status

Public Device Record Key: 5f7dfc47-3993-4486-9e22-8bbf97cc4851
Public Version Date: October 22, 2018
Public Version Number: 4
DI Record Publish Date: June 30, 2016