Duns Number:038000253
Device Description: 4F X 20CM SINGLE CT MIDLINE FULL NURSING KIT W/MAX BARRIER
Catalog Number
-
Brand Name
CT MIDLINE CATHETER
Version/Model Number
MLCT4100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2021
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PND
Product Code Name
Midline Catheter
Public Device Record Key
1ec9f6cf-5f38-479c-971f-f02da032b76c
Public Version Date
September 20, 2021
Public Version Number
5
DI Record Publish Date
October 31, 2015
Package DI Number
50884908125158
Quantity per Package
3
Contains DI Package
00884908125153
Package Discontinue Date
September 10, 2021
Package Status
Not 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |