Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Recognition 04/04/2016
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FR Recognition Number
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9-113
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StandardCEN EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties |
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Scope/AbstractSpecifies test methods for corrosion resistance, tensile properties, leakage of fluids and air, water flow rate and security of connectors. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)
Regulation Number |
Device Name |
Device Class |
Product Code |
§876.5980 |
Enteral Specific Transition Connectors |
Class 2 |
PIO |
§876.5980 |
Gastrointestinal Tubes With Enteral Specific Connectors |
Class 2 |
PIF |
§876.5980 |
Set, Gavage, Infant, Sterile |
Class 2 |
FHT |
§876.5980 |
String And Tubes, Gastrointestinal, To Locate Internal Bleeding |
Class 2 |
FFW |
§876.5980 |
Tube, Feeding |
Class 2 |
FPD |
§876.5980 |
Tube, Gastro-Enterostomy |
Class 2 |
KGC |
§876.5980 |
Tube, Nasogastric |
Class 2 |
BSS |
§876.5980 |
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression |
Class 2 |
FEF |
§876.5980 |
Tubes, Gastrointestinal (And Accessories) |
Class 2 |
KNT |
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Relevant FDA Guidance and/or Supportive Publications
Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications; Guidance for Industry and Food and Drug Administration Staff, Issued February 2015.
Reducing Risks through Standards Development for Medical Device Connectors: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm313322.htm
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology |
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