Duns Number:058614483
Device Description: Precision Chronic Catheter Kit,Symmetrical Tip,14.5 Fr/Ch (4.8 mm) x 28 cm
Catalog Number
8888145016P
Brand Name
Palindrome
Version/Model Number
8888145016P
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
K123196,K123196
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
2bf59514-2325-476f-8417-ce6051bead09
Public Version Date
August 24, 2021
Public Version Number
5
DI Record Publish Date
September 22, 2014
Package DI Number
20884521157993
Quantity per Package
5
Contains DI Package
10884521157996
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |