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Found 13 results
510(k) Data Aggregation
K Number
K250172Device Name
Green Card Bowie-Dick Test (BD115)
Manufacturer
SteriTec Products, Inc. (a Getinge Company)
Date Cleared
2025-02-20
(30 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SteriTec Products, Inc. (a Getinge Company)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
Device Description
The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.
The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.
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K Number
K083650Device Name
EMU-GRAPH 4 EMULATOR, MODEL CI 144
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2009-03-05
(86 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270° F) or 135° C (275° F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
| Temperature | Time |
|---------------|-----------|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |
Device Description
Not Found
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K Number
K080136Device Name
INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2008-08-15
(206 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.
Device Description
Not Found
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K Number
K052516Device Name
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2005-10-03
(19 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 121° C gravity steam sterilizers or 132° – 134° C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.
Device Description
Not Found
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K Number
K040901Device Name
STERITEC EMU-GRAPH, MODEL NO. CI 131/US
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2004-09-09
(155 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.
Device Description
SteriTec Integraph-E is a steam sterilization integrator. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.
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K Number
K024293Device Name
BOWIE-DICK MINI PAK, MODEL BD 115
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2003-08-11
(230 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
Device Description
Not Found
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K Number
K012732Device Name
INTEGRAPH FLASH, MODEL CI 110
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2002-03-04
(200 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-vacuum or gravity displacement steam sterilization process of 3 minutes or longer at 132° C (270° F), or a flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle in gravity displacement sterilizers. When exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.
Device Description
Not Found
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K Number
K010534Device Name
CROSS-CHECKS DUAL, MODEL CI 125
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2001-08-06
(164 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003533Device Name
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2001-02-07
(83 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003002Device Name
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
Manufacturer
STERITEC PRODUCTS, INC.
Date Cleared
2000-12-08
(73 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERITEC PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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