FDA.reportPublic FDA data

SteriTec Instant Readout Chemical Integrator Challenge Pack

Primary DI
00814434020219
Brand
SteriTec Instant Readout Chemical Integrator Challenge Pack
Company
STERITEC PRODUCT MFG. CO., INC.
Model
LT 101
Catalog number
LT 101
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814434020216PackageGS140In Commercial Distribution
00814434020219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081443402021610814434020216
00814434020219008144340202198144340202190814434020219

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius38 Degrees Celsius

Regulatory Flags#

DUNS number
622223196
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814434021230Getinge Assured MI Steam Migrating Integrator Strip613016068252020-07-17
00814434020264Getinge Assured Mini Bowie-Dick Test Pack61301606667613016066672016-09-23
00814434020172"SteriTec 3/4"" Green Tape"CI 159/.75, CI 165/.75CI 159/.75, CI 165/.752016-09-23
00814434020424Getinge Assure Green Tape 3/4 IN61301606668613016066682016-09-23
00814434020448Getinge Assure Green Tape 1 IN61301606669613016066692016-09-23
00814434020004SteriTec Cross-Checks DCI 105CI 1052016-09-23
00814434020011SteriTec Steri-Pak LF Bowie-Dick Test PackBD 111BD 1112016-09-23
00814434020028SteriTec Green Card Bowie-Dick TestBD 115BD 115, BD 115/1202016-09-23
00814434020066SteriTec IntegraphCI 101CI 101, CI 101/BR, CI 101/ITL2016-09-23
00814434020073SteriTec Cross-Checks EOCI 106CI 106, CI 106/ITL2016-09-23
00814434020080SteriTec Cross-Checks CI 107/USCI 107/US2016-09-23
00814434020097SteriTec Cross-Checks SCI 134/USCI 134/US2016-09-23
00814434020110SteriTec Sterilization TapeCI 122/.5, CI 164/.5CI 122/.5, CI 164/.52016-09-23
00814434020127SteriTec Sterilization TapeCI 122/.75, CI 164/.75CI 122/.75, CI 164/.752016-09-23
00814434020134SteriTec Sterilization TapeCI 122/1, CI 164/1CI 122/1, CI 164/12016-09-23
00814434020141SteriTec Sterilization Tape - BlueCI 123/1CI 123/12016-09-23
00814434020196SteriTec Steam Integrator X 2CI 143CI 1432016-09-23
00814434020202SteriTec Emu-Graph 4CI 144CI 1442016-09-23
00814434020226SteriTec Chemical Indicator Test Pack for Extended Timing CyclesLT 105LT 1052016-09-23
00814434020233SteriTec Instant Readout Class 6 Chemical Emulator Challenge PackLT 108LT 1082016-09-23

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