Duns Number:140727624
Device Description: Procedure Tray for placement of Adult or Pediatric PICC/Midline Catheters
Catalog Number
384827
Brand Name
Procedure Tray
Version/Model Number
384827
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
b29e7507-e66e-4225-ad14-b12a870eb938
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20886333210088
Quantity per Package
5
Contains DI Package
00886333210084
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 | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |