Duns Number:879875490
Device Description: Aerosol Holding Chamber for use with Metered-Dose Inhalers. Small compact size, dishwashe Aerosol Holding Chamber for use with Metered-Dose Inhalers. Small compact size, dishwasher safe. Portable for people on the go. Optimizes Inhaler Medication Benefits. Compatible with Mask Products. Anti-Static Delivery. Clinically Proven Effective.
Catalog Number
-
Brand Name
Microchamber
Version/Model Number
N/A
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
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
-
Product Code
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
e1c406e7-a52f-436f-a1a5-c119e8b5a08f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 04, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |