Extension Set

GUDID 19008247000843

Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer.

Biegler GmbH

Conduction blood/fluid warmer set
Primary Device ID19008247000843
NIH Device Record Key936f5ac1-5bb2-47ce-9c25-8f15defba9e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtension Set
Version Model Number46000
Company DUNS300451747
Company NameBiegler GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109008247000259 [Primary]
GS119008247000256 [Package]
Contains: 09008247000259
Package: [100 Units]
In Commercial Distribution
GS119008247000843 [Package]
Contains: 09008247000259
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-29
Device Publish Date2020-06-19

On-Brand Devices [Extension Set]

19008247000843Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler
19008247000249Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler
19008247000232Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler

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