Duns Number:312555782
Device Description: Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV sol Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Catalog Number
00000448
Brand Name
plasmatherm
Version/Model Number
US
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
-
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
BK100063
Product Code
KZL
Product Code Name
Device, Warming. Blood And Plasma
Public Device Record Key
ee273696-ba0e-4853-a48c-b8a5c8306956
Public Version Date
July 19, 2021
Public Version Number
5
DI Record Publish Date
October 13, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |