Duns Number:206449154
Device Description: The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0 The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/min) to a maximum of six patients via oxygen therapy masks. It also has a self-sealing outlet for connection of an additional respiratory therapy or ventilation device.The Multi Patient Unit is packed with 25’ Oxygen supply hose, Medium concentration masks and Oxygen tubing.
Catalog Number
01OR6304
Brand Name
O-Two
Version/Model Number
01OR6304
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
2a076ee9-704c-4f04-b27a-a1f2ad19d781
Public Version Date
October 24, 2019
Public Version Number
1
DI Record Publish Date
October 16, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |