Duns Number:002348191
Device Description: AQUAPAK Sterile Water for Inhalation 760 mL w/ 033 Nebulizer Adaptor
Catalog Number
037-33
Brand Name
HUDSON RCI
Version/Model Number
IPN040629
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
OGG
Product Code Name
Humidifier nebulizer kit
Public Device Record Key
a88d7f4d-6cf0-45a1-9434-add601386e9d
Public Version Date
November 15, 2019
Public Version Number
4
DI Record Publish Date
November 18, 2017
Package DI Number
14026704597175
Quantity per Package
10
Contains DI Package
24026704597172
Package Discontinue Date
September 30, 2019
Package Status
Not 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 |