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Cheeta

FDA UDI

Class II (US FDA UDI)

by True Indicating Llc

Identity

Trade Name
Cheeta FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
The Cheeta Type 5 Integrating Indicator for Steam CHE-CSPN-15G is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121 ° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121 °C/16.5 min., SV132°C/2.0min, SV134 °C/1.4 min. SV135°C/1.2 min. FDA UDI
Model / Reference
CHE-CSPN-15G FDA UDI
Description
The Cheeta Type 5 Integrating Indicator for Steam CHE-CSPN-15G is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121 ° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121 °C/16.5 min., SV132°C/2.0min, SV134 °C/1.4 min. SV135°C/1.2 min. FDA UDI

Identifiers

Primary DI / UDI-DI
00850064244052 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chemical/physical sterilization process indicator

Cheeta by True Indicating Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
True Indicating Llc

Sources (1)

  • FDA UDI e8845ba1-e96e-42cb-8877-47d037e5877b 35 fields · synced Jun 8, 2026