Duns Number:807537683
Device Description: 2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used 2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users.
Catalog Number
-
Brand Name
SureFlow
Version/Model Number
FM069-2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BXY
Product Code Name
Flowmeter, Calibration, Gas
Public Device Record Key
ab8f7e1d-c090-41a7-84d5-e52146d174d5
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
February 27, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 252 |