Duns Number:079152829
Device Description: CapMedic is an interactive smart inhaler add-on that provides guidance for correct and reg CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.
Catalog Number
-
Brand Name
CapMedic®
Version/Model Number
CAPMED-C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K183586
Product Code
BZK
Product Code Name
Spirometer, Monitoring (W/Wo Alarm)
Public Device Record Key
fe47fab2-a31c-4bd9-b5ec-b8a30d7be95f
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
March 08, 2021
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. | 2 |