MRB · Indicator, Biological, Liquid Chemical Sterilization Process
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | MRB |
|---|---|
| Device Name | Indicator, Biological, Liquid Chemical Sterilization Process |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | Jul 30, 2008 | SESE |
| K053212 | RAVEN PROPACT | Raven Biological Laboratories, Inc. | Feb 15, 2006 | SESE |
| K043135 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | Jan 13, 2005 | SESE |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Raven Biological Laboratories, Inc. | Mar 3, 2004 | SESE |
Top Applicants
- Raven Biological Laboratories, Inc. — 2 clearances
- Spsmedical Supply Corp. — 2 clearances
