Duns Number:063505010
Device Description: Holter Kit - 5 x 455 electrodes, 1 patient diary, 2 alcohol pads, 1 prep pad, 1 razor, 1 A Holter Kit - 5 x 455 electrodes, 1 patient diary, 2 alcohol pads, 1 prep pad, 1 razor, 1 AAA battery
Catalog Number
-
Brand Name
FH Medical
Version/Model Number
PASH5
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
71d4808f-a612-4f6a-9f3d-51db65c03fdc
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 |