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510(k) Data Aggregation

    K Number
    K080340
    Device Name
    COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Date Cleared
    2008-03-05

    (26 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVARTIS NUTRITION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).
    Device Description
    The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike with 1000 mL water bag is compatible with all SpikeRight compatible enteral feeding systems. The twist and lock feature ensures safe and effective connection and prevents inadvertent connections to IV sets. The 1000 mL formula vinyl bag with 1000 mL water bag has 50 mL graduations to make it easier for reading and better accuracy when filling. The different-colored print on the bags make it easy to identify water and formula and the nutrition orders can be written directly on the formula bag for convenience. Single Use Only. The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike is compatible with all SpikeRight compatible enteral feeding systems. The COMPAT pump set with the in-line "Y" adapter is DEHP and latex free. Easy to use "Y" adapter - simply disconnect "Y" adapter cap and insert syringe for flushing. The in-line "Y" saves time - no need to disconnect set from the feeding tube when flushing medications, water or bolus feeding. Ready to use. Single use only.
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    K Number
    K071191
    Device Name
    NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Date Cleared
    2007-07-23

    (84 days)

    Product Code
    FPD
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVARTIS NUTRITION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit is intended for use as a surgically place gastrostomy tube intended to deliver enteral feeding formulas directly into the small bowel (jejunum). The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients is accomplished surgically using standard surgical techniques. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration. The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowel with the jejunal feeding tube. This device is for use under medical supervision only. The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding is used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.
    Device Description
    The Novartis Nutrition COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube is packaged in a sterile kit. It is designed for easy intra-operative placement and facilitates immediate postoperative feeding into the jejunum. The two-tube system allows for easy placement and replacement in the event of a jejunal tube clog. The large gastrostomy tube provides access to the stomach for decompression and drainage. The system's jejunal feeding tube is easy to place intra-operatively through the gastrostomy tube into the small bowel using the innovative balloon tipped stylet provided in the kit. The major components of the kit include: - . 28 FR Silicone Gastrostomy Tube - 12 FR Polyurethane Jejunal Feeding Tube with Double Lumen FEED/DRAIN . adapter and radiopaque, flow-through tip - Preassembled disposable balloon tipped stylet The COMPAT administration set contains or attaches to the formula reservoir/container and provides the conduit to deliver the feeding solution to the patient's feeding tube via a feeding pump. The patient's feeding tube may be a variety of tubes including, but not limited to, a nasogastic tube, a gastrostomy tube, or a jejunostomy tube. The administration set attaches to the patient's feeding tube to provide the formula or feeding solution required.
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    K Number
    K001916
    Device Name
    COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Date Cleared
    2001-02-16

    (238 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVARTIS NUTRITION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991668
    Device Name
    COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Date Cleared
    1999-07-26

    (73 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVARTIS NUTRITION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novartis Nutrition COMPAT Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device delivers enteral solutions and medications directly into the small intestine. When direct access to the small bowel lumen is necessary, the tube may be placed, and positioned within the small bowel using an appropriate technique. It may be permanently fixed to the skin of the outer abdomen using the arternal retainer provided and suture, or another appropriate fixation technique.
    Device Description
    The Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use.
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    K Number
    K981323
    Device Name
    COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Date Cleared
    1998-10-09

    (179 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVARTIS NUTRITION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novartis Nutrition COMPAT Mini-G Feeding Tube Kit provides for the delivery of enteral formula through an externally minimized feeding tube. This replacement tube is used when there exists an established, well healed and mature stoma tract communicating between the stomach and external body surface. Externally minimized or low profile feeding devices are used to minimize the exposure of the tube outside of the patient's body and to provide an improved body image to the patient by concealing the feeding device under the clothing.
    Device Description
    The Novartis Nutrition COMPAT MINI-G Replacement Gastrostomy Tube kit is a Class II medical device and is intended for use as an enteral feeding tube to deliver feeding formula and/or medications to the stomach, as well as providing the ability to decompress and drain the stomach.
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