Duns Number:096372255
Device Description: HYDRO-TEMP® Cover with Foam and Acrylic
Catalog Number
-
Brand Name
DeRoyal
Version/Model Number
HNICU-04
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
Yes
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
FMT
Product Code Name
WARMER, INFANT RADIANT
Public Device Record Key
8bb7e851-01e9-46a3-824d-de2d40dfd7da
Public Version Date
August 11, 2021
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
30749756166325
Quantity per Package
100
Contains DI Package
00749756166324
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |