Duns Number:626238844
Device Description: DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER: CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER: CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT. CATALOG NUMBER 1304 IS 1 DISPENSER BOX CONTAINING 25 INDIVIDUAL LITEAIRE UNITS IN A SHIPPING CONTAINER. CATALOG NUMBER 1306 IS 4 DISPENSER BOXES, EACH CONTAINING 25 LITEAIRE UNITS (100 LITEAIRE UNITS IN TOTAL) IN A SHIPPING CONTAINER.
Catalog Number
1303, 1304, 1306
Brand Name
LITEAIRE
Version/Model Number
1303
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
-
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
91638060-dc53-4456-879c-333760ed6b35
Public Version Date
September 16, 2019
Public Version Number
7
DI Record Publish Date
September 21, 2016
Package DI Number
40383480000493
Quantity per Package
25
Contains DI Package
00383480000495
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |