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Found 7 results
510(k) Data Aggregation
K Number
K112268Device Name
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
Manufacturer
CODAN US CORP.
Date Cleared
2012-03-19
(224 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODAN™ SafeFeed Enteral Feeding Reservoir is intended for the storage and delivery of liquid medication, formula, and breast milk.
Device Description
The CODAN™ SafeFeed Enteral Feeding Reservoir is disposable and for single patient use only.
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K Number
K042693Device Name
IV ADMINISTRATION SET B400 SP
Manufacturer
CODAN US CORP.
Date Cleared
2004-10-21
(21 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.
Device Description
Not Found
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K Number
K033301Device Name
IV ADMINISTRATION AND CONNECT SETS
Manufacturer
CODAN US CORP.
Date Cleared
2004-03-04
(142 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CODAN US IV Administration sets, In-line sets and Connect Sets are indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.
Device Description
Not Found
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K Number
K021480Device Name
EXTENSION SET LIGHT-SAFE, MODEL BC565
Manufacturer
CODAN US CORP.
Date Cleared
2002-06-27
(50 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODAN US Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.
Device Description
Not Found
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K Number
K013714Device Name
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
Manufacturer
CODAN US CORP.
Date Cleared
2002-03-28
(140 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODAN IV Administration Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.
Device Description
Not Found
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K Number
K001872Device Name
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
Manufacturer
CODAN US CORP.
Date Cleared
2000-09-07
(79 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990711Device Name
CODAN CHEMOSPIKE
Manufacturer
CODAN US CORP.
Date Cleared
1999-04-13
(40 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CODAN US CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODAN Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the withdrawar of modication aring reconstitution of the drug in the vial and withdrawal of the drug from the vial.
Device Description
CODAN Chemospike
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