Duns Number:080384219
Device Description: This is a single patient multi use, hand held secretion clearance and lung expansion devic This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
Catalog Number
-
Brand Name
PocketPEP
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,K160636,K160636
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
46e0de36-4eb6-4ef3-aad4-9de95b362c68
Public Version Date
February 13, 2019
Public Version Number
5
DI Record Publish Date
January 02, 2018
Package DI Number
10851232007568
Quantity per Package
10
Contains DI Package
10851232007575
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 |