Duns Number:004239034
Device Description: 146 Transport Incubator Folding Stand, w/o tray
Catalog Number
-
Brand Name
146 Transport Incubator Folding Stand
Version/Model Number
0063105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 30, 2020
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
FPO
Product Code Name
Stretcher, Wheeled
Public Device Record Key
b3178fdb-f932-437a-a7cf-bfbb478e08fa
Public Version Date
November 26, 2020
Public Version Number
3
DI Record Publish Date
August 22, 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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 140 |