Duns Number:063505010
Device Description: Holter Kit - 1 pack of 7 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pads, 1 razo Holter Kit - 1 pack of 7 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pads, 1 razor, 7 strip tapes
Catalog Number
FHM255AC
Brand Name
Stable Base
Version/Model Number
FHM255AC
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
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
21e86be8-50ca-4ac2-bdeb-7eb48c069a3f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 30, 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 |