Duns Number:827221698
Device Description: eSwallow
Catalog Number
-
Brand Name
Eswallow
Version/Model Number
ESW-9050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 29, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
efd78a6d-d98a-4bf1-9f5d-29b2bf71a545
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
December 31, 2016
Package DI Number
80092237619458
Quantity per Package
4
Contains DI Package
30092237619453
Package Discontinue Date
May 29, 2018
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 62 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |
U | Unclassified | 2 |