True Indicating Sterilization Indicator Tape

Basic Information

• Brand Name: True Indicating Sterilization Indicator Tape
• Primary DI: 00860011103424
• Version / Model: CSWN-1T
• Company Name: True Indicating LLC
• Labeler DUNS: 116935598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-18
• Public Version: 1
• Public Version Date: 2025-03-26
• Public Version Status: New
• Public Device Record Key: 1168dcf9-31eb-44ef-a42f-c2681c92bc0a
• Distribution End Date: 2026-05-08

Device Description

The Sterilization indicator tape is designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off-yellow to Dark brown/Black. Use the Sterilization indicator tape in steam sterilization processes described below. 1. 121°C, 30 minutes; Gravity Steam 2. 132°C, 4 minutes; Dynamic Air Removal Steam 3. 135°C, 3 minutes; Dynamic Air Removal Steam

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011103424	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius