Fresenius

Basic Information

• Brand Name: Fresenius
• Primary DI: 10840861100542
• Version / Model: 04-9500-2
• Catalog Number: 04-9500-2
• Company Name: Fresenius Medical Care Holdings, Inc.
• Labeler DUNS: 958291411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2015-09-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 86475c02-9166-4153-a5e6-a96b5eef3288

Device Description

Transducer Protectors, bulk pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
FIB	PROTECTOR, TRANSDUCER, DIALYSIS	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32109	Haemodialysis system transducer protector	A sterile device designed to protect a haemodialysis system pressure monitor and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent cross-contamination by viruses, bacteria, and particulate matter while preventing the flow of fluids to the pressure monitor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20840861100549	GS1		10	In Commercial Distribution
Primary	10840861100542	GS1
Unit of Use	00840861100545	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003445	000