Duns Number:961027315
Device Description: Kendall DL Adapter for Nihon Kohden monitors, 6-lead, Reusable
Catalog Number
33548
Brand Name
Kendall
Version/Model Number
33548
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)
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
3621b67b-0d6b-4873-8a40-6bb37cff1e01
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
50885380171046
Quantity per Package
100
Contains DI Package
20885380171045
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |