Duns Number:010712461
Device Description: OSCILLATORY PEP THERAPY SYSTEM,VIBRAPEP,OPEP,INTRODUCER,T-PIECE,LATEX FREE,DEHP FREE
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
301-44F50-100
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
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
K153441,K153441,K153441
Product Code
BWF
Product Code Name
SPIROMETER, THERAPEUTIC (INCENTIVE)
Public Device Record Key
299691dc-919a-499c-9ad8-471f0a9de5ee
Public Version Date
June 22, 2021
Public Version Number
5
DI Record Publish Date
December 14, 2016
Package DI Number
00812574025408
Quantity per Package
12
Contains DI Package
00812574025392
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 | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |