Duns Number:079375431
Device Description: BALLARD* Closed Suction Catheter, Elbow, Neonatal/Pediatric
Catalog Number
206-4J
Brand Name
AVANOS
Version/Model Number
99331
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
74ec996a-b19d-4ebf-9c74-8c65b5927cd9
Public Version Date
June 16, 2020
Public Version Number
1
DI Record Publish Date
June 08, 2020
Package DI Number
20609038993311
Quantity per Package
2
Contains DI Package
10609038993314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |