Duns Number:791238046
Device Description: Neonatal PICC Insertion Tray - No Catheter
Catalog Number
-
Brand Name
NA
Version/Model Number
NPT-PIC-NC
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
-
Product Code
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
9663f1e9-0af5-4efd-b435-a3fc2532ee2e
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
March 19, 2019
Package DI Number
10858778006833
Quantity per Package
5
Contains DI Package
00858778006836
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |