Duns Number:092673953
Device Description: High Flow Cannula O2 Adapter for use with Fisher and Paykel circuit
Catalog Number
-
Brand Name
Adaptors/Connectors
Version/Model Number
0583
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
9b1fbc78-339f-4f00-b1e0-ecc762151148
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
September 30, 2020
Package DI Number
10709078012270
Quantity per Package
100
Contains DI Package
00709078012273
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |