Duns Number:044611812
Device Description: Hickman Hemodialysis/Apheresis Catheter 13.5F Dual-Lumen Catheter, 36cm Overall Length, 19 Hickman Hemodialysis/Apheresis Catheter 13.5F Dual-Lumen Catheter, 36cm Overall Length, 19cm Tip-to-Cuff Length, Standard Kit (with Peel-Apart Introducer)
Catalog Number
0600660
Brand Name
Hickman Hemodialysis/Apheresis Catheter
Version/Model Number
0600660
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
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
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
9bf8c22c-f9d3-4b03-be02-d2cda1d32235
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
June 24, 2015
Package DI Number
10801741037501
Quantity per Package
12
Contains DI Package
00801741037504
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |