Duns Number:002348191
Device Description: ADDIPAK 0.9% NaCl for Inhalation USP, 5 mL
Catalog Number
RHUD59U
Brand Name
HUDSON RCI
Version/Model Number
IPN916689
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142153,K142153,K142153
Product Code
CAF
Product Code Name
Nebulizer (direct patient interface)
Public Device Record Key
3f653040-a804-4a1c-a8f8-e75a1137d2f8
Public Version Date
August 26, 2020
Public Version Number
1
DI Record Publish Date
August 18, 2020
Package DI Number
34026704717812
Quantity per Package
10
Contains DI Package
14026704717818
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |