Duns Number:002065670
Device Description: Valve, Scavenging, MRI 3.0T, LeakTight Throttling, 90°, 3/4"-20 w/LockRing x 19mmM, w/ Che Valve, Scavenging, MRI 3.0T, LeakTight Throttling, 90°, 3/4"-20 w/LockRing x 19mmM, w/ CheckValve, Brass
Catalog Number
00-113-MRI
Brand Name
AincA®
Version/Model Number
00-113-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
CBN
Product Code Name
APPARATUS, GAS-SCAVENGING
Public Device Record Key
acee6527-37ba-40cb-a9b0-a623eff212df
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
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 |