Duns Number:002065670
Device Description: Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4"O2 x 1/4"Sensor, Chrome Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4"O2 x 1/4"Sensor, Chrome Brass
Catalog Number
00-488
Brand Name
AincA
Version/Model Number
00-488
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
-
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
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
e08f0ca9-f2a0-44d5-8c73-0956c21fbd74
Public Version Date
September 25, 2020
Public Version Number
3
DI Record Publish Date
August 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 561 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |