Duns Number:005192885
Device Description: IFM 0-15LPM TUBE ISO AIR DISS TYP E
Catalog Number
FI-T15IA-DN-E
Brand Name
Ohio
Version/Model Number
FI-T15IA-DN-E
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
34890acb-e9f8-410e-a4c6-536b6f0784c2
Public Version Date
July 26, 2022
Public Version Number
2
DI Record Publish Date
July 13, 2022
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 | 6453 |
2 | A medical device with a moderate to high risk that requires special controls. | 208 |