REVACLEAR

Basic Information

• Brand Name: REVACLEAR
• Primary DI: 07332414126209
• Version / Model: Revaclear 400
• Catalog Number: 114746M
• Company Name: Gambro Dialysatoren GmbH
• Labeler DUNS: 316150549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-08
• Public Version: 3
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 70a662a0-55d0-4714-ac15-8db5fb43b3b6

Device Description

Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis.

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	37332414126200	GS1	CASE	24	In Commercial Distribution
Primary	07332414126209	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130039	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	1.8	Square meter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 30 Degrees Celsius