Duns Number:785952607
Device Description: ADULT ENDOTRACHEAL CLOSED SUCTION SYSTEM 24 HOURS, SIZE 14F
Catalog Number
-
Brand Name
ADULT ENDOTRACHEAL CLOSED SUCTION SYSTEM 24 HOURS, SIZE 14F
Version/Model Number
3240001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
BSY
Product Code Name
Catheters, Suction, Tracheobronchial
Public Device Record Key
11079926-457d-4696-9c8c-e81bfda388b1
Public Version Date
July 26, 2022
Public Version Number
1
DI Record Publish Date
July 18, 2022
Package DI Number
05030267108947
Quantity per Package
15
Contains DI Package
05030267097807
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 |