Duns Number:038000253
Device Description: 4F X 20CM SINGLE CT MIDLINE FULL NURSING KIT W/MAX BARRIER
Catalog Number
MLCT4100
Brand Name
CT MIDLINE CATHETER
Version/Model Number
MLCT4100
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
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
099f34e9-9e39-4cb0-916f-a0763b39f80e
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 2021
Package DI Number
50884908163273
Quantity per Package
3
Contains DI Package
00884908163278
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |