FDA.reportPublic FDA data

STERIZONE® CI+ Chemical indicator

Primary DI
00690455438109
Brand
STERIZONE® CI+ Chemical indicator
Company
TSO3 Inc
Model
43810-1
Catalog number
43810-1
Device description
The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer.
Published
2016-09-14
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
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141698000STERIZONE CHEMICAL INDICATORTso3, Inc.2014-12-17JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690455438109PrimaryGS10
00690455438116Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690455438109006904554381096904554381090690455438109
00690455438116006904554381166904554381160690455438116

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-715-0003info@tso3.com

Regulatory Flags#

DUNS number
256900895
Device count
1000
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690455440102125-280 Solution™ for STERIZONE VP4 Sterilizer44010440102016-09-14
00690455426021STERIZONE® BI+ Self-contained Biological Indicator42602-142602-12016-09-14
00690455440003 STERIZONE® VP4 Sterilizer44000-R44000-R2016-09-14
00690455045604125-280 Solution™ for STERIZONE VP4 Sterilizer44010440102016-09-14
00690455440201 STERIZONE® VP4 Test Pack Kit44020440202016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
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00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
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00840456215203JMUJMU DENTAL, INCJOJ2026-06-05