Duns Number:097537435
Device Description: Kendall DL ECG Dual Connect Cable and Lead Wire System, 6-Lead, 144", Single Patient Use
Catalog Number
33154T
Brand Name
Kendall
Version/Model Number
33154T
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
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
9609eb96-2a75-41b4-9fc0-85e75680df0b
Public Version Date
September 16, 2020
Public Version Number
1
DI Record Publish Date
September 08, 2020
Package DI Number
20885380175005
Quantity per Package
5
Contains DI Package
10885380175008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |