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510(k) Data Aggregation
K Number
K060109Device Name
OMI RETRACTABLE SAFETY SYRINGE
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
2006-05-05
(112 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.
Device Description
The OMI Retractable Safety Syringe works like this: STEP 1 After cap removal, fluid draw-up and aspiration is unchanged from conventional syringes. STEP 2 As the plunger rod is depressed and the plunger stopper makes contact with the needle hub, the elastic membrane conforms to the conical shape of the needle hub. The plunger stopper membrane stretches until the plunger rod is fully depressed and maximum fluid is expelled from the svringe. STEP 3 At the point of full plunger rod depression, the application of the injection force overcomes the strength of the web joining the inner and outer portions of the needle hub. As this web fractures and the outer portion of the needle hub moves forward, the plunger stopper membrane is simultaneously pierced by the conical end of the hub, releasing the inner portion of the hub carrying the needle to be retracted into the hollow stem of the plunger rod by the coiled spring. The activation force is controlled. The extra pressure required at the end of the injection stroke to retract the needle is minimal. The entire procedure designed for singlehanded use, with no change to common habits. STEP 4 The fracturing of the needle hub and the piercing of the plunger stopper allow the needle to be forced into the plunger rod by the coiled spring. The speed of this retraction and the minimal dead space avoids blood or fluid spatter. Retraction is accompanied by an audible "click" and the highly visible separation of the needle hub. The syringe is EO sterilized, non-pyrogenic, and latex free.
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K Number
K050906Device Name
VITALCARE I.V. ADMINISTRATION SET
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
2005-08-23
(134 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.
Device Description
The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.
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K Number
K040916Device Name
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
2005-05-04
(391 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between the patient and examiner.
Device Description
VitalCare Powder Free Synthetic Vinyl Examination Glove. A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare professional and similar personnel to prevent contamination between the healthcare personnel and the patient's body, fluids, waste or environment.
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K Number
K031748Device Name
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
2003-08-27
(83 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitalCare Sterile Water and 0.9% Sodium Chloride. The10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.
Device Description
Sterile Water and 0.9% Sodium Chloride are products that have been used in the medical community for decades, the only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The syringes are manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives.
The containers are filled with distilled water and distilled saline solution, sealed, capped and gamma irradiated for single use only.
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K Number
K992289Device Name
VINYL POWDERED EXAM GLOVE / CAT.# 15-020
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
1999-08-04
(28 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient Vinyl Exam Glove, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Vinyl, Patient Exam Gloves, Powdered
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K Number
K983016Device Name
GAUZE, SPONGES, CAT # 11-003
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
1999-02-12
(168 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wound cover for patient care.
Device Description
Gauze, Sponges Various Sizes, Non-Sterile and Sterile
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K Number
K983716Device Name
VITALCARE DISPOSABLE VAGINAL SPECULUM
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
1998-12-23
(63 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
Device Description
Disposable Nonmetal Vaginal Speculum
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K Number
K982901Device Name
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
1998-12-21
(126 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
VITALCARE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
VitalCare Exam Gloves (Latex), Paude
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