Duns Number:169911828
Device Description: AIR/OXYGEN BLENDER,0-15 lpm, NIST, 60 psi
Catalog Number
-
Brand Name
MAXBLEND2
Version/Model Number
R229P01-024
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161718
Product Code
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
7cdfded2-3c53-4779-9b17-09a908f66ffa
Public Version Date
January 14, 2019
Public Version Number
4
DI Record Publish Date
March 09, 2017
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 |