Duns Number:169911828
Device Description: MicroMax Low Flow Air/Oxygen Blender with DISS Fitting
Catalog Number
R203P13
Brand Name
MicroMax
Version/Model Number
Low Flow DISS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
-
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
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
b4bb00c4-2d86-4e3a-9798-128661829931
Public Version Date
January 14, 2019
Public Version Number
3
DI Record Publish Date
November 01, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 280 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |