Duns Number:961394798
Device Description: The Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerit The Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10-Minute 270 degrees F/132 degrees C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.
Catalog Number
LCB054
Brand Name
Celerity
Version/Model Number
LCB054
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
-
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
0d8cf7e6-c6a3-4545-8a8a-c90c18124b23
Public Version Date
November 03, 2020
Public Version Number
2
DI Record Publish Date
July 19, 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 |