e-Lung

GUDID B720BX360ELUNG210

BRAINOMIX LIMITED

X-ray image interpretive software
Primary Device IDB720BX360ELUNG210
NIH Device Record Keya558dd08-bb57-46bc-92dc-8f0569da2524
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-Lung
Version Model Number2.1
Company DUNS216967482
Company NameBRAINOMIX LIMITED
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 Numberfalse
Manufacturing Datefalse
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
HIBCCB720BX360ELUNG210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-23
Device Publish Date2025-04-15

On-Brand Devices [e-Lung]

B720BX360ELUNG1001.0
B720BX360ELUNG2102.1

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