Administration Set Docking Station

Device Code: 2710

Product Code(s): ODI

Definition: Temporary Closing IV Administration Set. Temporary Aseptic Closure Of The Male Luer Connector Of The IV Tubing In Between Uses For The Life Of The Administration Set.

Device Classification Information

• Device Type ID: 2710
• Device Name: Administration Set Docking Station
• Physical State: Housing Is Made Of Polyethylene, Piston Is Made Of Silicone
• Technical Method: Temporary Barrier Against Airborne Contaminants
• Target Area: Indirect Contact, Intravascular Administration Of Fluids
• Regulation Description: Intravascular Administration Set.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5440 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: ODI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-273 ISO 23908 First Edition 2011-06-11
  Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling
• 6-318 ISO 8536-4 Fifth Edition 2010-10-01
  Infusion Equipment For Medical Use - Part 4: Infusion Sets For Single Use, Gravity Feed [Including: Amendment 1 (2013)]

Total Product Life Cycle

• Device Type ID: 2710
• Device: Administration Set Docking Station
• Product Code: ODI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intravascular Administration Set.
• CFR Regulation Number: 880.5440 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)	II	Aug-08-2018

TPLC Last Update: 2019-04-02 20:17:45