Bionova®

GUDID 07798164678441

Steam Test Pack PCD Kit (16 test packs and 4 control Bis)

TERRAGENE S.A.

Biological sterilization indicator
Primary Device ID07798164678441
NIH Device Record Key55ec03f6-573a-4e7e-bca6-9732477b4adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBionova®
Version Model NumberKPCD224-2
Company DUNS970856911
Company NameTERRAGENE S.A.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107798164678441 [Primary]

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-29
Device Publish Date2022-03-21

On-Brand Devices [Bionova®]

07798164679004"Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes"
07798164679547"Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes"
07798164679745Steam Test Pack PCD
07798164679301Self-contained Biological Indicator for monitoring vacunn assisted and gravity air-displacement
07798164679509Auto-Reader Incubator for biological indicators
07798164676706Auto-Reader Incubator for biological indicators
07798164675976Steam Test Pack PCD
07798375770118Self-contained Biological Indicator for monitoring steam sterilization processes
07798164679769Steam Test Pack PCD Kit
07798164678465Steam Test Pack PCD Kit
07798164678458Steam Test Pack PCD Kit
07798164678427Steam Test Pack PCD Kit
07798164678410Steam Test Pack PCD Kit
07798164676027Steam Test Pack PCD Kit
07798164679752Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
07798164679738Test pack for Steam sterilization processes
07798164678526Steam Test Pack PCD Kit (16 test packs and 4 control BIs)
07798164678519Steam Test Pack PCD Kit (25 test packs and 5 control BIs)
07798164678502Steam Test Pack PCD Kit (16 test packs and 4 control Bis)
07798164678496Steam Test Pack PCD Kit (25 test packs and 5 control BIs)
07798164678489Steam Test Pack PCD Kit (16 test packs and 4 control Bis)
07798164678472Steam Test Pack PCD Kit (25 test packs and 5 control BIs)
07798164678441Steam Test Pack PCD Kit (16 test packs and 4 control Bis)
07798164678434Steam Test Pack PCD Kit (25 test packs and 5 control BIs)
07798164675969Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
07798164675952Test pack for Steam sterilization processes
07798164675624Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
07798164675617Test pack for Steam sterilization processes
07798164675556Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
07798164675525Test pack for Steam sterilization processes
07798375770200Self-contained Biological Indicator for monitoring steam sterilization processes
07798164675051Auto-Reader Incubator for biological indicators
07798375770125Self-contained Biological Indicator for monitoring steam sterilization processes
07798375770132Self-contained Biological Indicator for monitoring Ethylene Oxide sterilization processes.

Trademark Results [Bionova]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIONOVA
BIONOVA
98860362 not registered Live/Pending
Tempus Ag, LLC
2024-11-19
BIONOVA
BIONOVA
90758141 not registered Live/Pending
Bionova, Inc.
2021-06-07
BIONOVA
BIONOVA
90190994 not registered Live/Pending
Bionova Ecosystem AB
2020-09-18
BIONOVA
BIONOVA
90083258 not registered Live/Pending
Alura, Inc.
2020-07-30
BIONOVA
BIONOVA
88661558 not registered Live/Pending
Finnegan, Shane
2019-10-21
BIONOVA
BIONOVA
88378931 not registered Live/Pending
ROBYN'S NATURAL POOLS INC.
2019-04-10
BIONOVA
BIONOVA
88059772 5810717 Live/Registered
Terragene S.A.
2018-07-31
BIONOVA
BIONOVA
81040580 1040580 Dead/Cancelled
Ling Products, Inc.
0000-00-00
BIONOVA
BIONOVA
78407144 not registered Dead/Abandoned
BioNova Medical Corporation
2004-04-23
BIONOVA
BIONOVA
77422954 not registered Dead/Abandoned
BioNova Medical Corporation
2008-03-14
BIONOVA
BIONOVA
77123906 not registered Dead/Abandoned
BioNova Medical Corporation
2007-03-06
BIONOVA
BIONOVA
76497358 2842541 Dead/Cancelled
Spectro BioNova GmbH
2003-03-12

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