Duns Number:079375431
Device Description: H9386102EN ENFit Bax AdaptaCap Size B
Catalog Number
H9386102EN
Brand Name
AVANOS
Version/Model Number
H9386102EN
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYX
Product Code Name
DISPENSER, LIQUID MEDICATION
Public Device Record Key
94f9452a-6621-469c-81da-a0d9a6be0bd9
Public Version Date
May 21, 2021
Public Version Number
1
DI Record Publish Date
May 13, 2021
Package DI Number
10350770003051
Quantity per Package
16
Contains DI Package
00350770003054
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 |