Duns Number:245253575
Device Description: A stainless steel tubular frame bassinet for use in the operating room and/or maternity su A stainless steel tubular frame bassinet for use in the operating room and/or maternity suite.
Catalog Number
ph-2655
Brand Name
S/S Tubular frame maternity bassinet
Version/Model Number
PH-2655
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
36eabad3-a326-4436-bf7a-e0dd1ac2111f
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 |