Duns Number:262605672
Device Description: RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce a more comfortable, flexible and effective therapy delivery system.
Catalog Number
-
Brand Name
RespIn
Version/Model Number
11
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
-
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
K121170
Product Code
BYI
Product Code Name
Percussor, Powered-Electric
Public Device Record Key
0ff94cec-4fff-4b1f-a20b-f95961c99d2c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 25, 2016
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. | 1 |