Duns Number:097736867
Device Description: 4F (1.33mm) x 50cm DUAL LUMEN CT PICC LONG WIRE KIT
Catalog Number
PFM2CT4DL
Brand Name
PFM PICC CT II
Version/Model Number
PFM2CT4DL
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
K083873,K083873,K083873
Product Code
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
020f4473-1880-483b-b793-1dd11f1ba2a3
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 09, 2015
Package DI Number
20813623017492
Quantity per Package
20
Contains DI Package
10813623017495
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 109 |