Duns Number:203298203
Device Description: VersaPAP™ Positive Airway Pressure Device
Catalog Number
12150194010
Brand Name
VersaPAP™ Positive Airway Pressure Device
Version/Model Number
121501
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2020
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
-
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
K173918,K173918
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
31aeff1c-5d15-4803-b743-fdf1fc7b7331
Public Version Date
April 23, 2020
Public Version Number
3
DI Record Publish Date
September 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |