Duns Number:004175550
Device Description: MXR FLOWMETER ASSEMBLY AUS
Catalog Number
-
Brand Name
MXR FLOWMETER ASSEMBLY AUS
Version/Model Number
C3000A
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
K923781
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
eef6e851-f91a-433f-8ebf-01e02c082834
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |