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Found 4 results
510(k) Data Aggregation
K Number
K031407Device Name
ROSS EMBRACE ENTERAL PUMP
Manufacturer
ROSS PRODUCT DIV. ABBOTT LABORATORIES
Date Cleared
2003-05-20
(15 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCT DIV. ABBOTT LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.
Device Description
Not Found
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K Number
K003047Device Name
AMBULATORY ENTERAL NUTRITION PUMP
Manufacturer
ROSS PRODUCT DIV. ABBOTT LABORATORIES
Date Cleared
2001-06-12
(256 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCT DIV. ABBOTT LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992494Device Name
FLEXIFLO ENTERAL FEEDING TUBE
Manufacturer
ROSS PRODUCT DIV. ABBOTT LABORATORIES
Date Cleared
1999-08-25
(30 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCT DIV. ABBOTT LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexiflo/ROSS Enteral Feeding Tube is intended for nasoenteric placement into the stomach or 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. This device is also indicated for small bowel feeding of 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 tube may also be used for gastric decompression or evacuation of gastric contents.
Device Description
Not Found
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K Number
K990863Device Name
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
Manufacturer
ROSS PRODUCT DIV. ABBOTT LABORATORIES
Date Cleared
1999-04-06
(21 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ROSS PRODUCT DIV. ABBOTT LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexiflo PolyG Gastrostomy Tube is intended for gastric placement through a mature gastrocutaneous fistula, or one created during a Stamm or Witzel procedure. 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. Enteral feeding may be indicated for patients with a functioning gut who require short- to long-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 tube may also be used for gastric decompression or evacuation of gastric contents.
Device Description
Modification to FlexiFlo PolyG® Gastrostomy Tube
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