Duns Number:097736867
Device Description: 5F (1.67mm) x 20cm Dual Lumen CT Midline
Catalog Number
PFM5DML20
Brand Name
primeMidline
Version/Model Number
PFM5DML20
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
69770d42-a445-4550-a3e8-9881396a5fef
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
April 25, 2018
Package DI Number
20813623011629
Quantity per Package
4
Contains DI Package
10813623011622
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 |