Duns Number:002065670
Device Description: Valve, Pressure Relief, 0-60 cmH2O Adjustable True APL Valve, MRI Cond 3T, 1/2"-20 Inlet, Valve, Pressure Relief, 0-60 cmH2O Adjustable True APL Valve, MRI Cond 3T, 1/2"-20 Inlet, Brass
Catalog Number
00-273-MRI
Brand Name
AincA
Version/Model Number
00-273-MRI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
f9b740bc-4bdd-445e-97f7-4183999fa69e
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 |