Duns Number:757634266
Catalog Number
AAM3010
Brand Name
Nasal PCA
Version/Model Number
Nasal Inhaler - No Lockout (10mL) Screw Top
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCO
Product Code Name
Inhaler, Nasal
Public Device Record Key
57d7679a-4bcc-4973-b650-3c07d9307bc8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 17, 2017
Package DI Number
09350902001393
Quantity per Package
20
Contains DI Package
09350902001386
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |