Duns Number:038000253
Device Description: 7F X 30CM DOUBLE LUMEN7F X 30CM INFUSION CATHETER SETINFUSION CA
Catalog Number
DMC2L-12S
Brand Name
N/AN/A
Version/Model Number
DMC2L-12S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 08, 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
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
a61bd6a9-611e-483b-9f6a-4394c7200946
Public Version Date
October 04, 2021
Public Version Number
4
DI Record Publish Date
August 29, 2019
Package DI Number
50884908146825
Quantity per Package
10
Contains DI Package
00884908146820
Package Discontinue Date
September 08, 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 |