Duns Number:251731105
Device Description: Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannu Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannula, Snap Electrodes and Snap Electrode Prep Pads.
Catalog Number
8128-20
Brand Name
MediByte Electrode Prep Kit
Version/Model Number
8128-20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
1bba935f-3e94-46fc-aa08-dbc30d945ded
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
November 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |