Duns Number:053146767
Device Description: Specialty Mouthpiece Adapter with 22mm ID fitting. Molded of polystyrene butadiene. Singl Specialty Mouthpiece Adapter with 22mm ID fitting. Molded of polystyrene butadiene. Single Patient Use.
Catalog Number
BE 120-22D
Brand Name
BE 120-22D Mouthpiece Adapter
Version/Model Number
BE 120-22D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
5bfb7372-90fd-4727-8673-5cb965e65d86
Public Version Date
March 23, 2020
Public Version Number
3
DI Record Publish Date
July 21, 2017
Package DI Number
M996BE12022D6
Quantity per Package
100
Contains DI Package
M996BE12022D0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |