Duns Number:038000253
Device Description: 9.5F X 90CM SINGLE LUMEN LT9.5F CVC BASIC KITCVC BASIC KIT
Catalog Number
MD28010911
Brand Name
LONG TERM CVCLONG TERM CVC
Version/Model Number
MD28010911
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
LJS
Product Code Name
Catheter, intravascular, therapeutic, long-term greater than 30 days
Public Device Record Key
563d18b1-dd6e-4823-9731-ba8f6efd785e
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
July 31, 2019
Package DI Number
50884908146085
Quantity per Package
10
Contains DI Package
00884908146080
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 |