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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IVAC CORP.KEOFEED IIENTERAL FEEDING TUBE

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IVAC CORP. KEOFEED II ENTERAL FEEDING TUBE   Back to Search Results
Catalog Number A92401
Event Date 01/28/1999
Event Type  Injury  
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Brand NameKEOFEED II
Type of DeviceENTERAL FEEDING TUBE
Baseline Brand NameENTERAL FEEDING TUBE
Baseline Generic NameFEEDING TUBE
Baseline Catalogue NumberA92401
Baseline Model NumberA92401
Baseline Device FamilyENTERAL
Baseline Device 510(K) NumberK850182
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/23/1984
Manufacturer (Section F)
IVAC CORP.
10300 campus point dr.
san diego CA 92121 1579
Manufacturer (Section D)
ALARIS MEDICAL SYSTEMS INC.
10221 wateridge circle
san diego CA 92121
Device Event Key202736
MDR Report Key217271
Event Key196067
Report Number2024124-1999-00001
Device Sequence Number1
Product CodeKNT
Report Source Manufacturer
Source Type Health Professional
Type of Report Initial,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/1999
Device Catalogue NumberA92401
Date Manufacturer Received03/02/1999
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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