Duns Number:785952607
Device Description: SUPERSET STRAIGHT CATHETER MOUNT 22F-22M/15F >= 70MM-150MM
Catalog Number
-
Brand Name
SUPERSET STRAIGHT CATHETER MOUNT 22F-22M/15F >= 70MM-150MM
Version/Model Number
3504000
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
217ae310-19b6-4851-afd0-b63e2a74fb9e
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 15, 2021
Package DI Number
05030267083893
Quantity per Package
75
Contains DI Package
05030267065837
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 |