AccessGUDID - DEVICE: Premixed Dialysate for Hemodiafiltration (09349285000208)

GUDID

Device Identifier (DI) Information

Brand Name: Premixed Dialysate for Hemodiafiltration
Version or Model: 5B7860
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5B7860
Company Name: Nikkiso Belgium BVBA

Primary DI Number: 09349285000208
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 370482633 *Terms of Use

Device Description: Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalities that employ hemodiafiltration, such as continuous arteriovenous hemodiafiltration (CAVHD) and Continuous Venous-Venous Hemodiafiltration (CVVHD), when treatment of actue renal failure patients with hypervolemia and uremia requires high solute clearance.

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":	No
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 [?]
Premarket Submission Number Not Available/Not Released

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: Minimize exposure to heat. Avoid excessive heat. Store at room temperature (25°C/77 °F): brief exposure up to 40 °C (104 °F) does not adversely affect the product
Storage Environment Temperature: less than 25 Degrees Celsius
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5000 Milliliter

Device Record Status

Public Device Record Key: 4ba1d9e2-d1c5-4a98-853b-5bd4b7efb9e6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 30, 2016