Instant 20s Indicator ISCS-05

GUDID 00860008246707

Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953 For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)

True Indicating LLC

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 ID00860008246707
NIH Device Record Key5a4e9b69-d0cc-46b5-8c07-03cb721bf630
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstant 20s Indicator
Version Model NumberISCS-05
Catalog NumberISCS-05
Company DUNS116935598
Company NameTrue Indicating LLC
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

Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008246707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTCIndicator, Chemical, Enzymatic, Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-22
Device Publish Date2023-05-12

Devices Manufactured by True Indicating LLC

00850064244007 - True Indicating2024-05-09 True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stea
00860011103493 - Larr-Test 242024-05-07 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
00860011103486 - True Indicating2024-04-15 True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stea
00860011103400 - Larr-Test 242023-11-10 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
00860008246707 - Instant 20s Indicator2023-05-22Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953 For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
00860008246707 - Instant 20s Indicator2023-05-22 Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological table
00197644183036 - Excelsior Scientific2023-05-22 Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological table
00197644080601 - Sterim2023-05-08 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
00197644533428 - Sterim2023-05-08 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
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