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Found 4 results
510(k) Data Aggregation
K Number
K082241Device Name
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
Manufacturer
Date Cleared
2008-10-30
(84 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
DALE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dale® ACE* Connector (*Access Controller for Enteral) is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines for up to 30 days. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.
Device Description
The Dale® ACE* Connector is a device that is inserted between the enteral tube and the fluid administration tubing or drain receptacle. It is designed to reduce the need for repeated and regular disconnection of the enteral tube from the associated tubing.
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K Number
K994300Device Name
NASOGASTRIC TUBE HOLDER, MODEL 160
Manufacturer
Date Cleared
2000-02-10
(51 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
DALE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The new Dale NasoGastric Tube Holder securely holds nasoenteric and nasogastric tubes in the nares.
Device Description
Not Found
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K Number
K964399Device Name
DALE ENDOTRACHEAL TUBE HOLDER 270/280
Manufacturer
Date Cleared
1997-01-28
(85 days)
Product Code
Regulation Number
868.5770Why did this record match?
Applicant Name (Manufacturer) :
DALE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K961693Device Name
DALE GASTROSTOMY TUBE HOLDER
Manufacturer
Date Cleared
1996-07-30
(90 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
DALE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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