Duns Number:259676661
Device Description: Ava Series Baby Bassinet, High pressure laminate, melamine, wood/veneer or seamless thermo Ava Series Baby Bassinet, High pressure laminate, melamine, wood/veneer or seamless thermofoil finish
Catalog Number
-
Brand Name
Amico Patient Care Corporation
Version/Model Number
AVA SERIES
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
-
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
NZG
Product Code Name
Bassinet, Hospital
Public Device Record Key
b19d2500-742e-49c1-8e8e-36a66d91fefc
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |