Duns Number:795104769
Device Description: Cool Kit w/Head Wrap, Patient Vest and Blanket Wrap for Legs
Catalog Number
ST-900
Brand Name
Soft-Temp
Version/Model Number
ST-900
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
ILO
Product Code Name
Pack, Hot Or Cold, Water Circulating
Public Device Record Key
4c000323-79fa-414c-9c03-7afa15ae0b2a
Public Version Date
August 06, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
20615089107003
Quantity per Package
4
Contains DI Package
10615089107006
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |