Duns Number:141668116
Device Description: Suction Catheter - 14Fr, Chimney Valve, Straight, Calibrated (1/pack)
Catalog Number
TRASC114SCV
Brand Name
Suction Catheter - 14Fr, Chimney Valve, Straight, Calibrated
Version/Model Number
TRASC114SCV
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
736115a9-0a86-437f-9b32-bc791fc932d9
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
July 31, 2018
Package DI Number
10848530085732
Quantity per Package
50
Contains DI Package
00848530085735
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |