Duns Number:097736867
Device Description: 3F (1.00mm) x 45cm SINGLE LUMEN CT PICC OTW KIT
Catalog Number
PFM2CT3SL
Brand Name
primePICC
Version/Model Number
PFM2CT3SL
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
K072391,K072391,K072391
Product Code
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
75d63b28-68cb-41cc-80c3-11f89043a903
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
January 19, 2017
Package DI Number
20813623013616
Quantity per Package
4
Contains DI Package
10813623013619
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 |