Duns Number:038000253
Device Description: 9.5F X 90CM SINGLE LUMEN LT CVC BASIC KIT
Catalog Number
-
Brand Name
Long Term CVC
Version/Model Number
MR28010911
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 18, 2019
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
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
d23d29d2-3efe-4858-8535-1b06a84de0ae
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
October 23, 2015
Package DI Number
50884908084271
Quantity per Package
10
Contains DI Package
00884908084276
Package Discontinue Date
November 18, 2019
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 |