Duns Number:368457563
Device Description: X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Snap, AHA, 3.6m/ 12ft
Catalog Number
2086349-006
Brand Name
Multi-Link™
Version/Model Number
2086349-006
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"
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
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
f01f45b3-8a13-45c0-803c-b25d6c736c66
Public Version Date
January 21, 2021
Public Version Number
1
DI Record Publish Date
January 13, 2021
Package DI Number
20190752141220
Quantity per Package
10
Contains DI Package
10190752141223
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |