Duns Number:782049217
Device Description: FMS HOLTER KIT - 1 PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 1 ALL PURPOSE SCRUB PAD, 2 A FMS HOLTER KIT - 1 PATIENT DIARY, 5 ELECTRODES, 1 PREP RAZOR, 1 ALL PURPOSE SCRUB PAD, 2 ALCOHOL PREPS, 2 AA ALKALINE BATTERIES.
Catalog Number
H-FMSI- 833
Brand Name
FLORIDA MEDICAL SALES INC.
Version/Model Number
FMSI-833
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
e9190c8a-bcaf-4ea9-a86b-355ceaf52149
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 28, 2016
Package DI Number
10857444006023
Quantity per Package
20
Contains DI Package
00857444006026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |