Duns Number:118492643
Device Description: HYPOTHERMIA PREVENTION BLANKET1 ea - 7.5' x 6.5' Blizzard Light Blanket
Catalog Number
04-105
Brand Name
Hypothermia Prevention Blanket
Version/Model Number
01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 10, 2022
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMD
Product Code Name
Pack, Hot Or Cold, Disposable
Public Device Record Key
919c3312-708d-4ced-b115-0e55a48574ff
Public Version Date
August 19, 2022
Public Version Number
4
DI Record Publish Date
December 13, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |