Duns Number:004324596
Device Description: SS8528 Stainless Steel Bassinet with basket, pad, 2 doors and casters w/ brakes
Catalog Number
-
Brand Name
UMF Medical
Version/Model Number
SS8528
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
4d1bf027-3619-4bb6-9379-3f53ab32af32
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 30, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 155 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |