SteriTec EO Gas Biological Test Pack with Instant Readout Indicator BI 102

GUDID 10814434020032

EO Gas Biological Test Pack with Instant Readout Indicator with 5 controls

STERITEC PRODUCT MFG. CO., INC.

Biological sterilization indicator Biological sterilization indicator
Primary Device ID10814434020032
NIH Device Record Key02be9455-3aba-44a0-87b8-ced1ad0a493c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec EO Gas Biological Test Pack with Instant Readout Indicator
Version Model NumberBI 102
Catalog NumberBI 102
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 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020035 [Primary]
GS110814434020032 [Package]
Contains: 00814434020035
Package: Case [30 Units]
In Commercial Distribution

FDA Product Code

FRCIndicator, Biological 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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