Duns Number:626238844
Device Description: DUAL SPRAY MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR AND 22MM O.D. X 22MM O.D. CONNEC DUAL SPRAY MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR AND 22MM O.D. X 22MM O.D. CONNECTIONS
Catalog Number
1024A
Brand Name
MINISPACER
Version/Model Number
1024A
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
f545b6d8-76f1-4f20-8e9b-38f3aa29bf7c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
10383480000270
Quantity per Package
50
Contains DI Package
00383480000273
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 |