Duns Number:005036025
Device Description: These kits are designed to provide the supplies you need for Holter testing. Kit contains: These kits are designed to provide the supplies you need for Holter testing. Kit contains: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and five electrodes.
Catalog Number
2-100-0080
Brand Name
Prep Kit - Midmark IQholter, 5-lead
Version/Model Number
2-100-0080
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MLO
Product Code Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Public Device Record Key
e7e994a4-c5bf-43e9-8f41-37b1637c1bf1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10841709100694
Quantity per Package
30
Contains DI Package
00841709100697
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |