Duns Number:169911828
Device Description: Low Flow System
Catalog Number
-
Brand Name
MicroMax Blender
Version/Model Number
R203P13-006
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053232
Product Code
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
6f45a816-04c7-44ba-8643-764cb3703bfe
Public Version Date
May 07, 2019
Public Version Number
2
DI Record Publish Date
January 14, 2019
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 |