Duns Number:532599255
Device Description: MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)
Catalog Number
572808
Brand Name
MRVLS
Version/Model Number
NA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 09, 2018
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
K060231,K060231,K060231
Product Code
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
ad23544e-2c78-4219-af8b-1ca28c514765
Public Version Date
November 02, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
17290102590015
Quantity per Package
45
Contains DI Package
07290102590018
Package Discontinue Date
May 09, 2018
Package Status
Not in Commercial Distribution
Package Type
dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |