Duns Number:194877072
Device Description: Wicking-style device that verifies when all critical parameters of steam sterilization hav Wicking-style device that verifies when all critical parameters of steam sterilization have been met during a specific sterilizer cycle.
Catalog Number
EMP-104
Brand Name
EMPlus Type 6 270F STEAM EMULATOR
Version/Model Number
EMP-104
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
K102363,K102363
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
7200d5c0-2a22-4728-9d8a-37920f8807c7
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
November 15, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |