Duns Number:600111512
Device Description: Airway Adaptor Adult /Pediatric Airway Adapter
Catalog Number
011401
Brand Name
Omnistream
Version/Model Number
011401
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
BZA
Product Code Name
CONNECTOR, AIRWAY (EXTENSION)
Public Device Record Key
69e87f72-c8dc-472a-8f0f-967cce539872
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
August 19, 2018
Package DI Number
20884521552033
Quantity per Package
25
Contains DI Package
10884521552036
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 154 |