Duns Number:868205779
Device Description: The Celerity STEAM Incubator is designed to incubate and automatically read the Celerity 2 The Celerity STEAM Incubator is designed to incubate and automatically read the Celerity 20 STEAM Biological Indicator (BI) for a fluorescent result within 20 minutes.
Catalog Number
LCB051
Brand Name
Celerity
Version/Model Number
LCB051
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 25, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
2f93017f-b919-4454-b508-6a50fda42128
Public Version Date
April 25, 2022
Public Version Number
4
DI Record Publish Date
June 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |