Duns Number:080935429
Device Description: Controller Tubing Extension Assembly,4' (1.2 m)
Catalog Number
9595
Brand Name
Kendall SCD
Version/Model Number
9595
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
JOW
Product Code Name
SLEEVE, LIMB, COMPRESSIBLE
Public Device Record Key
31c49a60-8bf9-4e89-86bf-e2de932e6e8a
Public Version Date
July 24, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884521006994
Quantity per Package
10
Contains DI Package
10884521006997
Package Discontinue Date
July 01, 2023
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |