Catalog Number
-
Brand Name
MAXFLO2
Version/Model Number
R223P02-006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 06, 2019
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
K113232
Product Code
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
749c0c4c-dc66-4a48-968c-7d7a6c9659b5
Public Version Date
May 07, 2019
Public Version Number
5
DI Record Publish Date
September 27, 2016
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 |