Duns Number:058614483
Device Description: Precision H Chronic Catheter Kit
Catalog Number
8888145068P
Brand Name
Palindrome
Version/Model Number
8888145068P
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"
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
K123196,K123196
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
3e0c245d-27bd-44d5-979f-6083e6991210
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2014
Package DI Number
20884521158426
Quantity per Package
5
Contains DI Package
10884521158429
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |