Duns Number:590153276
Device Description: Infant ventilator circuit (> 4 L/min) dual heated with MR290 autofeed chamber
Catalog Number
RT235
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
RT235
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K034026,K034026
Product Code
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
703f5ad5-3e0c-4aef-a561-c9ff7d8fe14d
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
September 08, 2016
Package DI Number
09420012412966
Quantity per Package
10
Contains DI Package
09420012431059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 159 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |