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510(k) Data Aggregation
K Number
K011467Device Name
ROSS EMBRACE PUMP SET
Manufacturer
Date Cleared
2001-08-10
(88 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K972437Device Name
ROSS ENTERAL FEEDING TUBE
Manufacturer
Date Cleared
1998-01-26
(210 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.
The external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel.
The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.
Device Description
The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding. The external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel. The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.
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K Number
K950017Device Name
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
Manufacturer
Date Cleared
1997-03-14
(801 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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