Duns Number:088302096
Device Description: Flowmeter, Digital Flexmount, 4 Cyl., SS
Catalog Number
26400-4CSS
Brand Name
Flowmeter, Digital Flexmount, 4 Cyl., SS
Version/Model Number
26400-4CSS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 31, 2199
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
K052335
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
9422ad07-a273-45f8-90ab-7fc4562ed5d0
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 31, 2018
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 | 344 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |