Duns Number:063505010
Device Description: 1 patient diary, 1 4x4 gauze, 2 AAA batteries, 1 razor, 2 alcohol pads, 5 lead lok electro 1 patient diary, 1 4x4 gauze, 2 AAA batteries, 1 razor, 2 alcohol pads, 5 lead lok electrodes
Catalog Number
FHM221
Brand Name
Stable Base
Version/Model Number
FHM221
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
a76761ff-88a3-41eb-bbb1-5d887e9bf322
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 04, 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. | 20 |