Duns Number:201179681
Catalog Number
HH-1R09-00-00
Brand Name
HOST 2, EPOC, REFURBISHED
Version/Model Number
HH-1R09-00-00
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEM
Product Code Name
Electrode, Ion Specific, Potassium
Public Device Record Key
50308621-f514-4b98-b571-a88e5f9528f5
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
July 05, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |