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Found 5 results
510(k) Data Aggregation
K Number
K965016Device Name
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
Manufacturer
GIBECK, INC.
Date Cleared
1997-12-02
(351 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
GIBECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Device Description
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are breathing circuit bacterial filters intended to remove microbiological and particulate matter from the gases in the breathing circuit as described in 21 CFR 868.5260. This product is substantially equivalent to the Dryden Mini Bacteria Filter.
The Iso-Gard Filter Angled/Iso-Gard Filter Straight are similar in design and function to the Dryden Mini Bacteria Filter with reduced size, dead space and lighter weight. The Iso-Gard Filter Angled/Iso-Gard Filter Straight incorporates a luer port in the housing to allow for connection of carbon dioxide or pressure monitoring equipment. The Iso-Gard Filter Angled also incorporates an angled housing to allow for the option of omitting the connection of angled patient connectors. The bacterial/viral filtration efficiency of the filter medium is 99+% for both the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter.
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K Number
K964377Device Name
THERMAL REGULATION SYSTEM BLANKET
Manufacturer
GIBECK, INC.
Date Cleared
1997-04-23
(173 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
GIBECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964382Device Name
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
Manufacturer
GIBECK, INC.
Date Cleared
1997-04-15
(162 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
GIBECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.
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K Number
K960511Device Name
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
Manufacturer
GIBECK, INC.
Date Cleared
1997-01-13
(343 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
GIBECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.
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K Number
K954828Device Name
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
Manufacturer
GIBECK, INC.
Date Cleared
1996-05-02
(195 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
GIBECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
combination products, i.e. bacterial/viral filters and heat and moisture exchangers
Device Description
combination products, i.e. bacterial/viral filters and heat and moisture exchangers
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