Duns Number:118492643
Device Description: HYPOTHERMIA MANAGEMENT SET1 ea - 7.5" x 6.5" Blizzard Light Blanket, 1 ea - 34" x 48" Read HYPOTHERMIA MANAGEMENT SET1 ea - 7.5" x 6.5" Blizzard Light Blanket, 1 ea - 34" x 48" Ready-Heat warming blanketWARNING: Do not place Ready-Heat on exposed skin.
Catalog Number
59-120
Brand Name
Hypothermia Management Set
Version/Model Number
00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
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
b78a6d56-7714-4d43-824d-9c217366a62b
Public Version Date
April 12, 2022
Public Version Number
2
DI Record Publish Date
April 04, 2018
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 |