Duns Number:169911828
Device Description: Manifold, 0-80 LPM Thorpe Flowmeter Green 60 PSI with DISS Fitting and Metal Muffled Adapt Manifold, 0-80 LPM Thorpe Flowmeter Green 60 PSI with DISS Fitting and Metal Muffled Adapter
Catalog Number
R220P64-101
Brand Name
Manifold
Version/Model Number
0-80 LPM Thorpe
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)
Yes
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
2c4944a1-d9fb-445c-b8b1-fced355877f3
Public Version Date
December 17, 2020
Public Version Number
1
DI Record Publish Date
December 09, 2020
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 |