DEVICE: Premixed Dialysate for Hemodiafiltration (00085412007380)

Device Identifier (DI) Information

Premixed Dialysate for Hemodiafiltration
5B7860
Not in Commercial Distribution
5B7860
BAXTER INTERNATIONAL INC.
00085412007380
GS1
December 17, 2015
1
005146311 *Terms of Use
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 acute renal failure patients with hypervolemia and uremia requires high solute clearance.
CLOSE

Device Characteristics

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

GMDN

[?]

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KPO DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Storage Environment Temperature: less than 25 Degrees Celsius
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.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 5000 Milliliter
CLOSE

Device Record Status

c7509812-f4c5-41b6-90d2-99358563111a
March 29, 2018
2
October 24, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50085412007385 2 00085412007380 2015-12-17 Not in Commercial Distribution CASE
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
CLOSE