Duns Number:785952607
Device Description: FIXED ELBOW, 15M - LUER PORT - 22M/15F
Catalog Number
-
Brand Name
FIXED ELBOW, 15M - LUER PORT - 22M/15F
Version/Model Number
2714000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
22a3296e-2978-4d23-92f8-bd064c980aea
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 15, 2021
Package DI Number
05030267046515
Quantity per Package
100
Contains DI Package
05030267064595
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |