Duns Number:063505010
Device Description: Holter Kit - 1 patient diary, 1 razor, 1 prep pad, 2 alcohol pads, 1 AAA battery, 10 x 455 Holter Kit - 1 patient diary, 1 razor, 1 prep pad, 2 alcohol pads, 1 AAA battery, 10 x 455 electrodes
Catalog Number
PASH5-2
Brand Name
FH Medical Services
Version/Model Number
PASH5-2
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
c66878f5-4a0b-4555-8917-1b6ba4cbcd69
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 |