Duns Number:300451747
Device Description: The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on th The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basisof a continuous flow warmer, where the heat from the heat exchanger is transferred via the extensionsets (consumables) to the liquid flowing within it.
Catalog Number
-
Brand Name
Blood and Infusion Warmer
Version/Model Number
BW 685
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121198
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
Public Device Record Key
a6c3749c-8004-431a-adb0-cd33b9f62d95
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
June 19, 2020
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. | 2 |