Duns Number:154454730
Catalog Number
MC-4475
Brand Name
Dual Swivel Elbow with Suction Port
Version/Model Number
MC-4475
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
e0766554-9dee-42eb-b02b-45795b757b55
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
September 15, 2017
Package DI Number
10858409005341
Quantity per Package
50
Contains DI Package
00858409005344
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 53 |
2 | A medical device with a moderate to high risk that requires special controls. | 5 |