Diacap®

Basic Information

• Brand Name: Diacap®
• Primary DI: 04046964320026
• Version / Model: 7204103
• Catalog Number: 7204103
• Company Name: B.Braun Avitum AG
• Labeler DUNS: 343689704
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2015-08-09
• Public Version: 4
• Public Version Date: 2023-12-01
• Public Version Status: Update
• Public Device Record Key: 334bc755-bbc9-400a-ae2f-12cb67d40880
• Distribution End Date: 2020-11-02

Device Description

Diacap Polysulfone® HI PS 18 Dialyzer

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
FJI	DIALYZER, CAPILLARY, HOLLOW FIBER	Gastroenterology, Urology	876.5820	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
Primary	04046964320026	GS1
Unit of Use	04039239089780	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Surface (m²) : 1.800 M2

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius