B-Capta

GUDID 04033817902836

LivaNova Deutschland GmbH

Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor
Primary Device ID04033817902836
NIH Device Record Keyad38cd24-55b9-4f99-a58b-6265c15bf55b
Commercial Distribution StatusIn Commercial Distribution
Brand NameB-Capta
Version Model NumberSensor Module
Company DUNS343225272
Company NameLivaNova Deutschland 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104033817902836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRYMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-24
Device Publish Date2021-05-14

On-Brand Devices [B-Capta]

04033817902836Sensor Module
04033817901631Arterial Sensor
04033817901624Venous Sensor

Trademark Results [B-Capta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
B-CAPTA
B-CAPTA
79240105 5724415 Live/Registered
SORIN GROUP ITALIA S.R.L.
2018-06-28

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