HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

FRESENIUS MEDICAL CARE NORTH AMERICA

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Hemosafe Patient Connector For Fresenius Bloodlines, Model 04-9100-0.

Pre-market Notification Details

• Device ID: K001873
• 510k Number: K001873
• Device Name: HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
• Classification: Set, Tubing, Blood, With And Without Anti-regurgitation Valve
• Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173
• Contact: Arthur Ellinsfeld
• Correspondent: Arthur Ellinsfeld; FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173
• Product Code: FJK
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-20
• Decision Date: 2000-07-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20840861100822	K001873	000