Duns Number:790605856
Device Description: 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG. 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG. AAMI color coded grabbers. Round peelable ribbon style wires. Wirelength: 3.3ft (1m). For use with trunk cables: M1663A and M1949A when paired with 989803173131 (disposable limb leads). 1 Sales Unit = 20 individually packagedlead sets.
Catalog Number
989803192141
Brand Name
ECG Cables and Leadsets
Version/Model Number
5-LEAD SET, DISPOSABLE, CHEST, AAMI
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
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
0b54b809-4d66-4be7-818e-237740a23530
Public Version Date
September 27, 2022
Public Version Number
8
DI Record Publish Date
November 28, 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 |