Duns Number:590153276
Device Description: Adaptor Kit For Drager Ventilator x 2
Catalog Number
RT061
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
RT061
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
ea283d0a-2926-4b05-9a23-d4c64b59711d
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
Package DI Number
09420012424013
Quantity per Package
50
Contains DI Package
09420012432384
Package Discontinue Date
-
Package Status
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 | 159 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |