Duns Number:080384219
Device Description: The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positiv The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen.
Catalog Number
-
Brand Name
OxyPAP
Version/Model Number
1
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"
Yes
For Single-Use
Yes
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
K192000,K192000,K192000,K192000,K192000
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
540ca6ce-3688-4c71-846c-c95a98eb75d3
Public Version Date
May 24, 2021
Public Version Number
2
DI Record Publish Date
February 24, 2020
Package DI Number
40851232007712
Quantity per Package
10
Contains DI Package
10851232007711
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |