Duns Number:079795848
Device Description: Huron 2 Drawer Bassinet
Catalog Number
M23-0000-0000
Brand Name
Medviron Bassinet
Version/Model Number
Huron 2 Drawer Bassinet
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)
-
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
296489e5-edbb-4182-abeb-0cfd79c234a2
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 13, 2018
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. | 17 |