Duns Number:097736867
Device Description: 4F x 20cm Single Lumen CT Midline
Catalog Number
PFM4SML20N
Brand Name
primeMIDLINE
Version/Model Number
PFM4SML20N
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
K173114,K173114,K173114
Product Code
PND
Product Code Name
Midline Catheter
Public Device Record Key
0d00522c-f15e-44e6-a96b-3698cc88da48
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
March 31, 2019
Package DI Number
20813623010141
Quantity per Package
4
Contains DI Package
10813623010144
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 |