Duns Number:002348191
Device Description: Gibeck Humid Flo Passive Humidification Kit
Catalog Number
19913-72
Brand Name
HUDSON RCI
Version/Model Number
IPN043828
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
9c9aafbc-5af1-4630-931e-2264dd7f0a6d
Public Version Date
February 10, 2020
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
24026704597332
Quantity per Package
10
Contains DI Package
04026704597338
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 |