Duns Number:004233490
Catalog Number
3500649
Brand Name
The Harris Products Group
Version/Model Number
FLWMTR,FME201 02-8 LPM W/O INLET
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
-
Product Code
CAX
Product Code Name
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Public Device Record Key
7aa24259-f870-4531-bf3f-addc6e108101
Public Version Date
November 20, 2019
Public Version Number
1
DI Record Publish Date
November 12, 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 | 55 |