Duns Number:002065670
Device Description: Valve, Scavenging, (+3" Taller), LeakTight Throttling, 90°, 3/4-20" x 19mmM, w/ CheckValve Valve, Scavenging, (+3" Taller), LeakTight Throttling, 90°, 3/4-20" x 19mmM, w/ CheckValve, Chrome Brass
Catalog Number
00-113-LONG
Brand Name
AincA®
Version/Model Number
00-113-LONG
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
CBN
Product Code Name
APPARATUS, GAS-SCAVENGING
Public Device Record Key
120cd39c-7613-4f41-bce8-6361ffee679e
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 |