Duns Number:543482946
Device Description: Berman airway is used to establish the airway and prevent the tongue fall and the airway b Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
Catalog Number
-
Brand Name
Ever One
Version/Model Number
/
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
e42884db-7fde-4aa1-b0c3-ef35ecc9aa76
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 10, 2020
Package DI Number
16946430410402
Quantity per Package
100
Contains DI Package
06946430410405
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |