Duns Number:785952607
Device Description: T-PIECE 22M/15F - 22F - 22F
Catalog Number
-
Brand Name
T-PIECE 22M/15F - 22F - 22F
Version/Model Number
1983000
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
-
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
ae709ea5-35c0-42e6-b5b5-da7ca59a5830
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 28, 2021
Package DI Number
05030267006298
Quantity per Package
20
Contains DI Package
05030267057832
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 |