SteriTec Green Card Bowie-Dick Test Starter Kit BD 116

GUDID 30814434020715

8 Kits containing 1 holder + 31 tests

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator
Primary Device ID30814434020715
NIH Device Record Key9c922074-0781-43e3-9216-7374852ea269
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec Green Card Bowie-Dick Test Starter Kit
Version Model NumberBD 116
Catalog NumberBD 116
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
GS100814434020714 [Primary]
GS110814434020711 [Package]
Contains: 00814434020714
Package: Box [30 Units]
In Commercial Distribution
GS120814434020718 [Package]
Contains: 10814434020711
Package: Kit [31 Units]
In Commercial Distribution
GS130814434020715 [Package]
Contains: 20814434020718
Package: Case [8 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

Devices Manufactured by STERITEC PRODUCT MFG. CO., INC.

10814434020803 - SteriTec Green Tape 3/4"2022-06-17
10814434021312 - SteriTec Green Tape 1"2022-06-17
10814434021633 - Getinge Assured Green Tape 3/4"2022-06-17
10814434021640 - Getinge Assured Green Tape 1"2022-06-17
30814434021231 - Getinge Assured MI Steam Migrating Integrator Strip2020-07-27
10732224109265 - Crosstex International2020-05-06 Sure Check Strip
20814434020619 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm2019-11-08
20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm2019-11-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.