Duns Number:038000253
Device Description: 5F X 13CM DOUBLE LUMEN INFUSION CATHETER SET WITH MINI SCALPEL
Catalog Number
-
Brand Name
INFUSION CATHETER
Version/Model Number
MC2LP-5S-ID
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
54a7c820-5315-4894-bfd3-ecbba15be1fb
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
April 20, 2016
Package DI Number
50884908028503
Quantity per Package
10
Contains DI Package
00884908028508
Package Discontinue Date
January 29, 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 |