Duns Number:783518983
Device Description: Inhaler chamber for use with inhaler (not included) for infants. Includes infant mask.
Catalog Number
7560
Brand Name
Pro Comfort Inhaler Space Chamber w/ INFANT mask
Version/Model Number
2.4.7
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCQ
Product Code Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Public Device Record Key
58a8601d-92d8-4c73-ab60-d27c8919af2b
Public Version Date
August 10, 2022
Public Version Number
2
DI Record Publish Date
March 23, 2020
Package DI Number
10850632007567
Quantity per Package
50
Contains DI Package
00850632007560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |