Duns Number:785952607
Device Description: STRAIGHT CONNECTOR 15M-15F,MDI INSERT TOWARDS 15F TAPER
Catalog Number
-
Brand Name
STRAIGHT CONNECTOR 15M-15F,MDI INSERT TOWARDS 15F TAPER
Version/Model Number
1947003
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
0f3191f5-9389-4e43-8e7a-45cf93f5f237
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 14, 2021
Package DI Number
05030267084203
Quantity per Package
100
Contains DI Package
05030267084180
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 |