Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-245: ISO 8536-4 Fifth edition 2010-10-01, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. (General Plastic Surgery/General Hospital)

Date of Standard: 2010.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

All Intravenous, Infusion sets and accessories

Processes Affected:

510(k), PMA, PDP, IDE, HDE

Type of Standard:

Vertical, International

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§880.5440	Adminstration Set Docking Station	Class 2	ODI
§880.5440	Check Valve, Retrograde Flow (In-Line)	Class 2	MJF
§880.5440	Filter, Infusion Line	Class 2	FPB
§880.5440	Intravenous Extension Tubing Set	Class 2	OJA
§880.5440	Microfilter, Blood Transfusion	Class 2	CAK
§880.5440	Set, Administration, Intravascular	Class 2	FPA
§880.5440	Set, Blood Transfusion	Class 2	BRZ
§880.5440	Set, I.V. Fluid Transfer	Class 2	LHI
§880.5440	Stopcock, I.V. Set	Class 2	FMG
§880.5440	Tubing, Fluid Delivery	Class 2	FPK

Regulation Number	Device Name	Device Class	Product Code
§880.5440	System/Device, Pharmacy Compounding	Class 2	NEP