Duns Number:078330362
Device Description: Accessory for the CritiCool /Allon 2001 systems. A body wrap connected to the thermoregul Accessory for the CritiCool /Allon 2001 systems. A body wrap connected to the thermoregulation system.
Catalog Number
500-03125
Brand Name
ThermoWrap™
Version/Model Number
Infant, 7.0–11Kg, (single)
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
c207fa16-2d63-43d5-a60b-5d4741ec355d
Public Version Date
September 09, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
37290012127305
Quantity per Package
24
Contains DI Package
07290012127304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |