U&U Bowie-Dick Test Pack
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143629 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The U&U Bowie-Dick Test Pack is a chemical indicator designed for verifying the effectiveness of physical or chemical sterilization processes. According to the nomenclature authority classification, it functions as an Indicator, Physical/Chemical Sterilization Process, ensuring that sterilization cycles achieve the required conditions for microbial kill.
This test pack is supplied as a single-use item and is intended for use in general hospital settings. It is not MRI-safe and must be handled in accordance with sterilization protocols. The device is authorized under FDA 510K and MDR, with a classification as a Class II medical device (OpenFDA: device_class=2). Storage and handling should comply with manufacturer instructions to maintain integrity until use.
Frequently asked questions
What is the primary purpose of the U&U Bowie-Dick Test Pack in a hospital setting?
The U&U Bowie-Dick Test Pack is designed to verify the effectiveness of sterilization processes—both physical and chemical—in hospital environments. It ensures that sterilization cycles meet the required conditions for microbial kill, helping maintain the integrity of sterilization protocols.
Is the U&U Bowie-Dick Test Pack intended for reuse, or is it a single-use item?
The U&U Bowie-Dick Test Pack is explicitly labeled as a single-use item. This means it should be discarded after one use to ensure accurate and reliable verification of sterilization cycles.
Can this test pack be used in MRI environments, or are there any safety concerns?
The U&U Bowie-Dick Test Pack is explicitly stated as not MRI-safe. It must be handled in accordance with standard sterilization protocols and should not be used in MRI environments due to potential safety risks.
What regulatory pathways has this device undergone, and where is it authorized?
The U&U Bowie-Dick Test Pack has been authorized under both the FDA 510K pathway and the EU MDR (Medical Device Regulation). It is classified as a Class II medical device and is intended for use in general hospital settings, as indicated by its regulatory filings.
How should the U&U Bowie-Dick Test Pack be stored to maintain its integrity before use?
The device must be stored and handled according to the manufacturer’s instructions to preserve its integrity. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, adherence to general sterilization protocol guidelines is critical to ensure the test pack remains effective until use.
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.
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 | K143629 | Class II | Active |
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Manufacturer
- Manufacturer
- U&U Medical Technology Co, Ltd.
Sources (2)
- FDA 510(k) K143629 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026