OCI · Indicator, Physical/Chemical, Storage Temperature
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | OCI |
|---|---|
| Device Name | Indicator, Physical/Chemical, Storage Temperature |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063759 | HEATMARKER TIME TEMPERATURE INDICATOR | Temptime Corporation | Aug 15, 2007 | SESE |
Top Applicants
- Temptime Corporation — 1 clearance
