Duns Number:080384219
Device Description: A handheld oscillating positive expiratory pressure device with the ability to deliver sup A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
Catalog Number
538
Brand Name
PocketPEP Advantage with OxyJET
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
-
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
K160636,K160636
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
f73a2b13-48a3-489f-b7aa-574eb8d61cd1
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 10, 2020
Package DI Number
30851232007722
Quantity per Package
10
Contains DI Package
10851232007728
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 |