Duns Number:300451747
Device Description: Disposable product for single use only. Sterile and pyrogen-free flowtube. For use with Bi Disposable product for single use only. Sterile and pyrogen-free flowtube. For use with Biegler blood and infusion warmer.
Catalog Number
-
Brand Name
Extension Set
Version/Model Number
46000
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
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
K121198,K121198
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
Public Device Record Key
936f5ac1-5bb2-47ce-9c25-8f15defba9e1
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
June 19, 2020
Package DI Number
19008247000843
Quantity per Package
20
Contains DI Package
09008247000259
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |