Duns Number:961394798
Device Description: The Celerity 20 STEAM Biological Indicator for IUSS is used to monitor the critical parame The Celerity 20 STEAM Biological Indicator for IUSS is used to monitor the critical parameters of steam sterilization cycles.
Catalog Number
LCB058
Brand Name
Celerity
Version/Model Number
LCB058
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
K202721,K202721
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
59792c55-fe5d-4d5b-9244-585ae809e0ea
Public Version Date
January 28, 2021
Public Version Number
1
DI Record Publish Date
January 20, 2021
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 |