Duns Number:002348191
Device Description: ThermaGard Electronically Controlled Nebulizer Heater For Use with HUDSON RCI REF 1770 Var ThermaGard Electronically Controlled Nebulizer Heater For Use with HUDSON RCI REF 1770 Variable Concentration Large Volume Nebulizer
Catalog Number
5705
Brand Name
HUDSON RCI
Version/Model Number
IPN914467
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
-
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
K880473,K880473
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
422a4b44-f037-416f-8e82-59610a302fee
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 29, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |