Duns Number:206449154
Device Description: The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distre The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distress at the flow rate demanded by the patient.
Catalog Number
01DV3000
Brand Name
Oxygen Demand Valve
Version/Model Number
01DV3000
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
K922810,K922810
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
5aba5d3b-90f3-4462-8cc3-749cd7f3f270
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 2015
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 |