Duns Number:118492643
Device Description: HAWK Advanced Hypothermia Management Set1 ea - 23" x 20" HAWK Waring Grid w/ absorbent pad HAWK Advanced Hypothermia Management Set1 ea - 23" x 20" HAWK Waring Grid w/ absorbent pad; 1 ea - 32" x 81" Thermal Patient Litter SystemWarning: Not for use on infants. Do not separate the HAWK Warming Grid from the absorbent pad. Device has the potential to produce burns. Always monitor and reassess during use.
Catalog Number
59-320
Brand Name
HAWK Advanced Hypothermia Management Set
Version/Model Number
02
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
9a2310c1-cac7-4fe0-99a1-0ee7b6775b3d
Public Version Date
September 07, 2022
Public Version Number
1
DI Record Publish Date
August 30, 2022
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 |