STERRAD BI TEST PACK
Device Facts
| Record ID | K921909 |
|---|---|
| Device Name | STERRAD BI TEST PACK |
| Applicant | Johnson & Johnson Medical, Inc. |
| Product Code | FRC · General Hospital |
| Decision Date | Oct 1, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
