SteriTec Steri-Pak LF Bowie-Dick Test Pack BD 111

GUDID 10814434020018

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator
Primary Device ID10814434020018
NIH Device Record Key25ddf8ea-41fe-4204-a8c9-78bbcfab0dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec Steri-Pak LF Bowie-Dick Test Pack
Version Model NumberBD 111
Catalog NumberBD 111
Company DUNS622223196
Company NameSTERITEC PRODUCT MFG. CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020011 [Primary]
GS110814434020018 [Package]
Contains: 00814434020011
Package: Case [20 Units]
In Commercial Distribution

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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