Duns Number:391906658
Device Description: Medical Device ECG Cable 10 leads for connecting GLOBE® SYSTEM monitor to Snap ECG Electro Medical Device ECG Cable 10 leads for connecting GLOBE® SYSTEM monitor to Snap ECG Electrodes
Catalog Number
71734-US
Brand Name
INTEGRAL PROCESS Cables & Leadwires
Version/Model Number
ECG Cable
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
-
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
K162768
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
633a66b2-1c96-4591-b5f2-897dcf3aa0c6
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 2022
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. | 13 |