Duns Number:590153276
Device Description: CIRCUIT KIT NEO LOW-FLOW - Infant Ventilator Circuit (0.3 to 4L/min) Single Heated With MR CIRCUIT KIT NEO LOW-FLOW - Infant Ventilator Circuit (0.3 to 4L/min) Single Heated With MR290 Autofeed Chamber
Catalog Number
RT226
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
RT226
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
K020332,K020332
Product Code
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
76a9d543-c9a4-44dd-8b3c-5f7e81fa2613
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
August 02, 2022
Package DI Number
09420012411327
Quantity per Package
10
Contains DI Package
09420012431165
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 |