Duns Number:790605856
Device Description: MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color coded (white MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color coded (white mono colorlead wires). Single Patient Use. Cable length 85 cm (33.5 .) 1 Sales unit = 20 patient cables.
Catalog Number
989803172131
Brand Name
ECG Electrodes
Version/Model Number
CBL ECG 5 LEAD GRABBER IEC, SPU, TELE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSI
Product Code Name
DETECTOR AND ALARM, ARRHYTHMIA
Public Device Record Key
84b8b3c1-4648-4793-8215-9aa918674356
Public Version Date
March 07, 2022
Public Version Number
5
DI Record Publish Date
March 25, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |