Duns Number:868205779
Device Description: The Celerity HP Incubator was designed exclusively to incubate and read activated Celerity The Celerity HP Incubator was designed exclusively to incubate and read activated Celerity 20 HP Biological Indicators.
Catalog Number
LCB046
Brand Name
Celerity
Version/Model Number
LCB046
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
12b705e0-0fde-457b-a319-8f588324f1e0
Public Version Date
April 25, 2022
Public Version Number
8
DI Record Publish Date
November 17, 2017
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 |