Duns Number:218172765
Device Description: Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Fle Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.
Catalog Number
PCC079
Brand Name
Celerity
Version/Model Number
PCC079
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
K213262,K213262,K213262
Product Code
QKM
Product Code Name
A chemical vapor sterilization multivariable chemical indicator
Public Device Record Key
03f6286a-95e8-4b41-be4a-a36c292786db
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
Package DI Number
50724995218589
Quantity per Package
40
Contains DI Package
10724995218581
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |