Duns Number:007941230
Device Description: Tray Dressing Change Neonatal Picc MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
CLC1056
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
OWL
Product Code Name
Peripheral catheter insertion kit
Public Device Record Key
eb268d14-1788-45c0-99f9-f1e7c9f7eb3f
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
50885632109148
Quantity per Package
20
Contains DI Package
10885632109140
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |