Duns Number:961394798
Device Description: The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low T The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunction or major repairs and for routine requalification testing.
Catalog Number
LCB045
Brand Name
Celerity
Version/Model Number
LCB045
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
K173488,K183294,K220473,K173488,K183294,K220473
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
aed11fa0-d51c-4537-a2b8-3d205abf15ab
Public Version Date
April 19, 2022
Public Version Number
3
DI Record Publish Date
July 02, 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 |