Duns Number:600111512
Device Description: Filter Line, MRI XL, Short-term use: Procedural/Emergency
Catalog Number
-
Brand Name
Microstream Advance
Version/Model Number
MVXL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
80448c83-6fea-4b13-9e24-43a0972fdd1d
Public Version Date
May 03, 2022
Public Version Number
3
DI Record Publish Date
March 27, 2020
Package DI Number
10884521761940
Quantity per Package
25
Contains DI Package
20884521761947
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 154 |