STERRAD™ Chemical Indicator (CI) Strip (14100) +5 more models
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- STERRAD™ Chemical Indicator Strip EUDAMEDSterrad FDA UDI
- Generic Name
- Chemical/physical sterilization process indicator FDA UDI
- Device Name
- STERRAD™ Chemical Indicator Strip EUDAMEDChemical Indicator Strip FDA UDI
- Model / Reference
- 14100 EUDAMEDFDA UDI
- Description
- Chemical Indicator Strip FDA UDI
Identifiers
- Catalog Number
- 14100 FDA UDI
- Primary DI / UDI-DI
- 10705037016198 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A020000000000002JM EUDAMED
- Unit of Use DI
- 80705037016197 EUDAMED
- FDA Product Code
- JOJ FDA 510(k)FDA UDI
- EMDN Code
- S900199 DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Chemical/physical sterilization process indicator FDA UDI
- Models / Variants
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
These devices are physical and chemical indicators used to verify the completion of sterilization processes. The STERRAD Chemical Indicator Strip and SEALSURE Tape provide visual confirmation of exposure to sterilization cycles, differentiating processed from unprocessed medical device packages. The STERRAD VELOCITY Biological Indicator assesses microbial lethality, while the ULTRA GI Process Challenge Device evaluates sterilization efficacy under specific conditions. The STERRAD VELOCITY Reader enables reading and interpreting biological indicator results.
The STERRAD Chemical Indicator Strip and SEALSURE Tape are single-use, non-sterile indicators designed for use with STERRAD Sterilization Systems. The STERRAD VELOCITY Biological Indicator and Reader are reusable components of a biological monitoring system, intended for hospital or clinical settings. The ULTRA GI Process Challenge Device is a single-use device for validating sterilization processes. All devices comply with FDA 510(k) and MDR regulatory requirements, with classification under Class II medical devices for physical/chemical sterilization process indicators.
Manufacturer's product page: STERRAD VELOCITY™ System
Frequently asked questions
Are these indicators reusable, or are they designed for single-use only? What does this mean for my facility’s inventory management?
The STERRAD Chemical Indicator Strip and SEALSURE Tape are explicitly labeled as single-use, meaning each strip or roll should be discarded after one sterilization cycle. In contrast, the STERRAD VELOCITY Biological Indicator and its Reader are reusable components of a biological monitoring system, designed for repeated use in hospital or clinical settings. This distinction impacts inventory planning—single-use items require frequent restocking, while reusable components reduce waste but need proper cleaning and maintenance between cycles.
How do I know if a STERRAD sterilization cycle has been completed successfully using these indicators?
The STERRAD Chemical Indicator Strip and SEALSURE Tape provide visual confirmation of exposure to the sterilization process. After a cycle, a color change indicates the package was processed, while no change means it was not. For microbial lethality verification, the STERRAD VELOCITY Biological Indicator must be used with the STERRAD VELOCITY Reader to assess whether the sterilization cycle achieved the required microbial kill. The ULTRA GI Process Challenge Device further validates efficacy under specific conditions, ensuring the sterilization system performs as intended.
What storage conditions should I follow for these indicators to maintain their integrity?
While the data does not specify exact storage conditions, the STERRAD Chemical Indicator Strip and SEALSURE Tape are non-sterile and intended for use with STERRAD systems. For optimal performance, they should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. The reusable STERRAD VELOCITY Biological Indicator and Reader require proper cleaning and maintenance per manufacturer guidelines to ensure accurate readings. Always check the packaging for any additional storage instructions.
Are these indicators compatible with all STERRAD sterilization systems, or are there specific models I should confirm?
The STERRAD Chemical Indicator Strip (14100) and SEALSURE Tape (14202NL) are designed specifically for STERRAD Sterilization Systems, but compatibility should be confirmed with your system’s model to ensure proper function. The STERRAD VELOCITY Biological Indicator (43210) and Reader (43220) are part of a dedicated biological monitoring system for STERRAD, requiring integration with compatible STERRAD systems. The ULTRA GI Process Challenge Device (43400) is used to validate sterilization processes but may require alignment with specific system settings or protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SEALSURE™ Chemical Indicator (CI) Tape and STERRAD™ Chemical ... - ASP, STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE ..., STERRAD Indicator Strip 14100 | Sterilization Assurance
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K234084 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products, Inc.
Sources (3)
- FDA 510(k) K234084 24 fields · synced Sep 18, 2026
- FDA UDI 2c5d32b4-1202-48ab-b469-9856b04f1c08 37 fields · synced May 29, 2026
- EUDAMED 828b7b2e-f50b-4cb5-9571-96db793d063f 61 fields · synced Jul 14, 2026