Duns Number:080384219
Device Description: This is a single patient, multi use, hand held secretion clearance and lung expansion devi 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
vPEP-HC
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
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
bd06a7e8-7cf3-4ce6-a7dc-a439eec4196f
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 24, 2018
Package DI Number
30851232007029
Quantity per Package
10
Contains DI Package
10851232007025
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 |