Broncoflex XFlo

GUDID 03664977000103

Broncoflex XFlo 5.6/3.0

AXESS VISION TECHNOLOGY

Flexible video bronchoscope, single-use
Primary Device ID03664977000103
NIH Device Record Key1182b967-23e2-4170-a8e9-47d05bc32290
Commercial Distribution StatusIn Commercial Distribution
Brand NameBroncoflex XFlo
Version Model Number10040001
Company DUNS285985615
Company NameAXESS VISION TECHNOLOGY
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103664977000103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-28
Device Publish Date2025-07-18

Devices Manufactured by AXESS VISION TECHNOLOGY

03664977000103 - Broncoflex XFlo2025-07-28Broncoflex XFlo 5.6/3.0
03664977000103 - Broncoflex XFlo2025-07-28 Broncoflex XFlo 5.6/3.0
03664977000011 - Easy BAL Clip™2023-08-07 The Easy BAL Clip™ is a non-sterile, single-use device designed as an add-on to the Broncoflex™ during a Broncho Alveolar La
03664977010034 - Broncoflex Vortex2020-12-18 Broncoflex Vortex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reu
03664977020033 - Broncoflex Agile2020-12-18 Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reus
03664977030032 - Screeni2020-12-18 Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display li

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