STERIZONE® CI+ Chemical indicator 43810-1
GUDID 00690455438109
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.
TSO3 Inc
Chemical/physical sterilization process indicator| Primary Device ID | 00690455438109 |
| NIH Device Record Key | d071fc4d-56cf-491b-9bdf-db49aeb5043c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERIZONE® CI+ Chemical indicator |
| Version Model Number | 43810-1 |
| Catalog Number | 43810-1 |
| Company DUNS | 256900895 |
| Company Name | TSO3 Inc |
| Device Count | 1000 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com | |
| Phone | 1-866-715-0003 |
| info@tso3.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690455438109 [Primary] |
| GS1 | 00690455438116 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141698
FDA Product Code
| JOJ | Indicator, Physical/Chemical Sterilization Process |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-14 |
Devices Manufactured by TSO3 Inc
| 00690455426021 - STERIZONE® BI+ Self-contained Biological Indicator | 2018-07-06 The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor int |
| 00690455438109 - STERIZONE® CI+ Chemical indicator | 2018-07-06The 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. |
| 00690455438109 - STERIZONE® CI+ Chemical indicator | 2018-07-06 The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and |
| 00690455440003 - STERIZONE® VP4 Sterilizer | 2018-07-06 The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of |
| 00690455045604 - 125-280 Solution™ for STERIZONE VP4 Sterilizer | 2018-07-06 The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active |
| 00690455440201 - STERIZONE® VP4 Test Pack Kit | 2018-07-06 Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor |
Trademark Results [STERIZONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERIZONE 90028682 not registered Live/Pending |
Tso3 Inc. 2020-06-30 |
 STERIZONE 81033763 1033763 Dead/Cancelled |
Telecommunications Industries, Inc. 0000-00-00 |
 STERIZONE 79296165 not registered Live/Pending |
Viral & Bacterial Solutions Pty Ltd 2020-09-23 |
 STERIZONE 78417553 not registered Dead/Abandoned |
Podd, Stephen 2004-05-12 |
 STERIZONE 77094595 3432185 Live/Registered |
TSO3 INC. 2007-01-30 |
 STERIZONE 75015781 not registered Dead/Abandoned |
LifeTECH Corporation 1995-11-07 |
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