Duns Number:038000253
Device Description: 14F (4.7MM) X 20CM SLX Hemo-Cath® DOUBLE LUMEN (CATHETER ONLY)
Catalog Number
-
Brand Name
SLX Hemo-Cath®
Version/Model Number
MC061443
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 04, 2022
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
LFJ
Product Code Name
CATHETER, SUBCLAVIAN
Public Device Record Key
26e72248-129f-44c7-8e72-340eef7abf38
Public Version Date
May 09, 2022
Public Version Number
4
DI Record Publish Date
October 23, 2015
Package DI Number
50884908083274
Quantity per Package
10
Contains DI Package
00884908083279
Package Discontinue Date
May 04, 2022
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 |