Exeltra Dialyzer

Basic Information

• Brand Name: Exeltra Dialyzer
• Primary DI: 00085412071213
• Version / Model: 170
• Catalog Number: 5M2120
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 3
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: efd6a472-900e-4d12-89a1-71ebfa6b59e6
• Distribution End Date: 2019-12-31

Device Description

Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDI	Dialyzer, high permeability with or without sealed dialysate system	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47072	Hollow-fibre haemodialysis dialyser, single-use	A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412071218	GS1	CASE	24	Not in Commercial Distribution	2019-12-31
Primary	00085412071213	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid direct exposure to sunlight and vibrations. Avoid excessive changes in relative humidity.
• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius