Duns Number:790605856
Device Description: ECG Trunk Cable. AAMI/IEC. Connects MX4x Series 3-,5- and 6-wire lead sets to 12-pin ECG s ECG Trunk Cable. AAMI/IEC. Connects MX4x Series 3-,5- and 6-wire lead sets to 12-pin ECG socket instruments (used on Bedside Monitors). Trunk Cable Length = 2.7 m (9 ft). Reusable. 1 Sales unit= 1 cable.
Catalog Number
989803172221
Brand Name
ECG Electrodes
Version/Model Number
ECG Trunk Cable AAMI/IEC
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
-
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
05faad43-60eb-4444-b8d6-3e5d65bf9d3e
Public Version Date
March 04, 2022
Public Version Number
6
DI Record Publish Date
November 22, 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 |
|---|---|---|
| 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 |