Duns Number:005146311
Device Description: The FIBRINOTHERM Heating and Stirring Device is designed to facilitate the reconstitution The FIBRINOTHERM Heating and Stirring Device is designed to facilitate the reconstitution of Baxter's two component Fibrin Sealant kit. The device consists of a heating block and an integrated magnetic stirrer.
Catalog Number
0600047
Brand Name
Fibrinotherm
Version/Model Number
0600047
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRG
Product Code Name
BLOCK, HEATING
Public Device Record Key
39074d91-7ab7-4f55-9420-fca8821f5556
Public Version Date
October 19, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2018
Package DI Number
55413760308376
Quantity per Package
1
Contains DI Package
05413760308371
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |