Duns Number:194877072
Device Description: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
Catalog Number
EMS-052
Brand Name
PassPort MAIL-IN SYSTEM
Version/Model Number
EMS-052
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)
Yes
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
e3b5acd9-5841-4a6f-9586-830d148632f8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 15, 2016
Package DI Number
50732224720048
Quantity per Package
4
Contains DI Package
10732224720040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |