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Found 8 results
510(k) Data Aggregation
K Number
K973497Device Name
HUBERLOC
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1998-01-13
(120 days)
Product Code
LJT, MSD
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this device is for the removal of 90° winged infusion sets, THE GRIPPER™, and VasTack™, having a 1-1/2" needle or shorter from implanted ports and the containment of the used needle until placed in a sharps container.
Device Description
The MedCare Medical Group's HuberLoc is a device designed to assist in the removal and containment of Huber needles. The device consists of three plastic molded components; an inner slide and an outer housing, right and left halves. The HuberLoc is slid over the Huber needle, so the needle cannula is in the slot of the forks. Pressure is applied to the top of the HuberLoc to support the skin and the infusion port with your thumb. The first and middle finger of the same hand pull on the wings of the inner slide, in opposition to the thumb pressure. This action removes the Huber needle and draws it into the outer housing. The inner slide locks into place and contains the needle. The operation utilizes an easy one handed technique. This eliminates any rebound reflex. The HuberLoc is provided sterile, disposable, and for single patient use.
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K Number
K970152Device Name
BIOPSY TRAY
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1997-03-05
(48 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures.
Device Description
The Biopsy Tray is intended to conveniently provide the auxiliary components utilized during biopsy procedures. The components are items that are commonly used during a variety of biopsy procedures. The Biopsy Tray provides the convenience of having these items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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K Number
K962849Device Name
CATHETER INSERTION TRAY
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1996-10-07
(77 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Catheter Insertion Trav is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.
Device Description
The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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K Number
K961075Device Name
MEDCARE REGIONAL ANETHESIA KIT
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1996-09-06
(172 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.
Device Description
The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.
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K Number
K962328Device Name
SINGLE USE INSTRUMENT TRAY
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1996-08-09
(64 days)
Product Code
FSM
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962527Device Name
GENERAL PURPOSE DENTAL TRAY
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1996-08-01
(35 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.
Device Description
The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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K Number
K961880Device Name
MEDCARE SUCTION CONNECTING TUBING
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1996-07-19
(65 days)
Product Code
GCX
Regulation Number
880.6740Why did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Y ankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
Device Description
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs
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K Number
K961167Device Name
MEDCARE TRACHEOSTOMY CARE TRAY
Manufacturer
MEDCARE MEDICAL GROUP, INC.
Date Cleared
1996-07-02
(99 days)
Product Code
LRQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDCARE MEDICAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
Device Description
The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.
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