Instant 20s Indicator

Primary DI
00860008246707
Brand
Instant 20s Indicator
Company
True Indicating LLC
Model
ISCS-05
Catalog number
ISCS-05
Device description
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® 7953For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
Published
2023-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTCIndicator, Chemical, Enzymatic, Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTCIndicator, Chemical, Enzymatic, Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210481000Instant 20s IndicatorTrue Indicating, LLC2021-12-14MTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008246707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008246707008600082467078600082467070860008246707

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
419-476-7119info@trueindicating.com

Regulatory Flags#

DUNS number
116935598
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011103424True Indicating Sterilization Indicator TapeCSWN-1T2025-03-18
00860011103486True IndicatingMSCST-05-252024-04-05
00850064244045LarrCSPN-15L2025-04-02
00850064244052CheetaCHE-CSPN-15G2025-04-02
00850064244038True IndicatingCSPN-152025-02-27
00197644183036Excelsior ScientificISCS-05EISCS-05E2023-05-12
00850064244007True IndicatingMSCST-05MSCST-052024-05-01
00860011103493Larr-Test 24MSCST-05LMSCST-05L2024-04-29
00860011103400Larr-Test 24MSCST-05LMSCST-05L2023-11-02
00197644080601SterimSRI-050SRI-0502023-04-28
00197644533428SterimSBI-100SBI-1002023-04-28
00860008246714True IndicatingMSCST-05MSCST-052023-04-28
00860008246738Excelsior ScientificMSCS-05EMSCS-05E2023-04-28
00860008246745Larr-Test 24MSCST-05LMSCST-05L2023-04-28
00860008246769ApprovedMSCST-05SFMSCST-05SF2023-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197644183036Excelsior ScientificTrue Indicating LLCMTC2023-05-12