Duns Number:245253575
Device Description: This silverpine (light green) bassinet is designed and skillfully crafted to fit perfectly This silverpine (light green) bassinet is designed and skillfully crafted to fit perfectly into the maternity ward of your hospital. Manufactured from the highest quality materials to provide a safe and comfortable surrounding for the infant.
Catalog Number
PH-2695SP
Brand Name
THE KERRI BEAR MATERNITY BASSINET
Version/Model Number
PH-2695SP
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
eb1fd253-8c3c-4004-84d9-bab56cc52b8f
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 07, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |