Primary Device ID | 03664977000103 |
NIH Device Record Key | 1182b967-23e2-4170-a8e9-47d05bc32290 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Broncoflex XFlo |
Version Model Number | 10040001 |
Company DUNS | 285985615 |
Company Name | AXESS VISION TECHNOLOGY |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03664977000103 [Primary] |
EOQ | Bronchoscope (Flexible Or Rigid) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-28 |
Device Publish Date | 2025-07-18 |
03664977000103 - Broncoflex XFlo | 2025-07-28Broncoflex XFlo 5.6/3.0 |
03664977000103 - Broncoflex XFlo | 2025-07-28 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 Vortex | 2020-12-18 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 Agile | 2020-12-18 Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reus |
03664977030032 - Screeni | 2020-12-18 Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display li |