Duns Number:600111512
Device Description: Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing
Catalog Number
-
Brand Name
Microstream Advance
Version/Model Number
MVANOH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
233f1a15-4ecd-4237-9ae9-51a831791f75
Public Version Date
April 29, 2022
Public Version Number
4
DI Record Publish Date
July 23, 2020
Package DI Number
10884521761827
Quantity per Package
25
Contains DI Package
20884521761824
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 |