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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 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. (General Plastic Surgery/General Hospital)

Date of Standard: 2011. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
(3)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(4)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Medical devices with sharps injury prevention features
Processes Affected:
510(k), PMA, IDE, Pre-IDE, HDE, Design Control Input
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.4730 Needle, Dental Class 1 DZM
§880.5200 Catheter, Umbilical Artery Class 2 FOS
§880.5200 Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days Class 2 FOZ
§880.5200 Heparin, Vascular Access Flush Class 2 NZW
§880.5200 Peripheral Catheter Insertion Kit Class 2 OWL
§880.5200 Saline, Vascular Access Flush Class 2 NGT
§880.5200 Water, Vascular Access Flush Class 2 NZX
§880.5440 Adminstration Set Docking Station Class 2 ODI
§880.5440 Check Valve, Retrograde Flow (In-Line) Class 2 MJF
§880.5440 Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Class 2 ONB
§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
§880.5570 Container, Sharps Class 2 MMK
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5570 Needle, Hypodermic, Single Lumen, Reprocessed Class 2 NKK
§880.5570 Port, Intraosseous, Implanted Class 2 MHC
§880.5725 Accessories, Pump, Infusion Class 2 MRZ
§880.5725 Pump, Infusion Class 2 FRN
§880.5725 Pump, Infusion, Analytical Sampling Class 2 LZF
§880.5725 Pump, Infusion, Elastomeric Class 2 MEB
§880.5725 Pump, Infusion, Enteral Class 2 LZH
§880.5725 Pump, Infusion, Gallstone Dissolution Class 2 MHD
§880.5725 Pump, Infusion, Insulin Class 2 LZG
§880.5725 Pump, Infusion, Insulin Bolus Class 2 OPP
§880.5725 Pump, Infusion, Ophthalmic Class 2 MRH
§880.5725 Pump, Infusion, Pca Class 2 MEA
§880.5860 Injector, Pen Class 2 NSC
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5860 Syringe, Piston, Reprocessed Class 2 NKN
§880.5965 Port & Catheter, Implanted, Subcutaneous, Intravascular Class 2 LJT
§880.5965 Port Introducer Kit Class 2 OKE
§880.5965 Port, Protector/Cushion Class 2 OBK
§880.5970 Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days Class 2 LJS
§880.5970 Implanted Subcutaneous Securement Catheter Class 2 OKC
§880.5970 Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position Class 2 OMF
§880.5970 Tunneled Catheter Remover Class 2 ODY
§880.6920 Introducer, Syringe Needle Class 2 KZH
§880.6960 Ear Irrigation Kit Class 1 OGQ
§880.6960 Syringe, Irrigating (Non Dental) Class 1 KYZ
Relevant Guidance:
Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, CDRH issued, 2005
FDA Technical Contact:
 Mary Brooks
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3453
  Silver Spring MD 20993
  301/796-6078
  email: mary.brooks@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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