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Found 63 results
510(k) Data Aggregation
K Number
K023673Device Name
AIRLIFE DEMAND NASAL CANNULA
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2003-05-02
(182 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
Device Description
Airlife Demand Nasal Cannula
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K Number
K023419Device Name
TRILAMINATE DRAPES/TIBURON
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2003-02-11
(123 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Convertors®Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
These drapes will be comprised of an outer and inner layer of polyolefin-based nonwovens with an inner layer of polyolefin-based film. Several drapes will also have clear polyethylene side panels on either end of the drapes.
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K Number
K024120Device Name
MODIFICATION TO TEMNO BIOPSY NEEDLES
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2003-01-15
(30 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Semi-Automated Temno® Biopsy Device is a system used for tissue sampling from several different organs, including, but not limited to, the Kidney, Liver, Breast and Prostate.
This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.
Device Description
Needles are permanently attached to an automated device comprised of a spring that activates a stylet and cannula in a specified cutting sequence. The needle cuts and traps the tissue samples, which are substantially equivalent to samples obtained with similar devices currently in the market.
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K Number
K024292Device Name
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2003-01-09
(16 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
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 examiner's hand or finger to prevent contamination between patient and examiner. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
Device Description
Positive Touch Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.
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K Number
K024102Device Name
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2002-12-18
(6 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
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 examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
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K Number
K023425Device Name
DRAPES WITH ABSORBENT REINFORCEMENT
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2002-11-06
(26 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Convertors®Surgical Drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
The drapes are comprised of a base layer of nonwoven material to which the absorbent reinforcement structure is laminated.
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K Number
K022765Device Name
NITRILE POWDER-FREE EXAMINATION GLOVES
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2002-10-11
(52 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
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 examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
Device Description
Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
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K Number
K023170Device Name
NITRILE POWDER-FREE EXAMINATION GLOVES
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2002-10-09
(16 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
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 examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
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K Number
K023167Device Name
BREATHABLE SURGICAL GOWN
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2002-10-02
(9 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Convertors®Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms. body fluids and particulate material.
Device Description
The Breathable Surgical Gown consists of an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing a an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt nonwoven (SMS) with a polyolefin-based film reinforcement.
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K Number
K012931Device Name
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2002-08-20
(354 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
ALLEGIANCE HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A sterilization container system is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
This container system is intended to be used in STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes.
Device Description
The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is a reusable device which features an assortment of container designs and sizes, and inner basket and platform types.
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