Duns Number:038000253
Device Description: 16F X 28CM PRE-CURVED SPLIT CATH® III CATHETER SET (CUFF 23CM FROM TIP)
Catalog Number
-
Brand Name
SPLIT CATH® III
Version/Model Number
AAC23608
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 23, 2020
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"
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
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
edcef34d-68b2-4729-a7d8-8bd6ef9d15fe
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
April 29, 2016
Package DI Number
50884908000929
Quantity per Package
5
Contains DI Package
00884908000924
Package Discontinue Date
June 23, 2020
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |