FDA.reportPublic FDA data

BFlex™

Primary DI
00879123008565
Brand
BFlex™
Company
Verathon Medical (Canada) ULC
Model
BFlex™ 2 Regular 5.0
Catalog number
0570-0423
Device description
BFlex™ 2 Regular 5.0 Single-Use Bronchoscope
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183256000GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc2019-01-04EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879123008562PackageGS15In Commercial Distribution
00879123008565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087912300856210879123008562
00879123008565008791230085658791230085650879123008565

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Regulatory Flags#

DUNS number
243738320
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00879123009012BFlex™BFlex™ 2 SamplePro™0574-02632026-05-29
00879123009340GlideScope®GlideScope® Core™ 10 FHD Essential Configuration0270-1212-FHD2026-05-29
00879123009357GlideScope®GlideScope® Core™ 15 FHD Essential Configuration0270-1213-FHD2026-05-29
00840432200056Verathon®Verathon® Essential Workstation0800-07002026-05-28
00840432200001CFlex™Single-Use Cystoscope, Standard Deflection0570-04552026-05-15
00840432200018CFlex™Single-Use Cystoscope, Reverse Deflection0570-04592026-05-15
00840432200063CystoView™Essential Configuration with Holder and QuickConne0270-12032026-05-15
00840432200117CystoView™CystoView™ Monitor0570-04652026-05-15
00840432200308CystoView™Clamp Kit Configuration with Holder and QuickConne0270-12022026-05-15
00840432200315CystoView™Clamp Kit Configuration with QuickConnect™ Cable0270-12012026-05-15
00840432200322CystoView™Monitor with QuickConnect™ Cable0270-12002026-05-15
00879123007841GlideScope®ClearFit™ Video Baton0570-04252025-08-01
00879123008381GlideScope®ClearFit™ Hyperangle 3 Cover0574-02422025-08-01
00879123008398GlideScope®ClearFit™ Hyperangle 4 Cover0574-02432025-08-01
00879123008428GlideScope®ClearFit™ Miller 2 Cover0574-02472025-08-01
00879123008442GlideScope®ClearFit™ MAC 2 Cover0574-02442025-08-01
00879123008459GlideScope®ClearFit™ MAC 3 Cover0574-02452025-08-01
00879123008466GlideScope®ClearFit™ MAC 4 Cover0574-02462025-08-01
00879123007612GlideScope®GlideScope® Go™ 2 Monitor Configuration0270-11862025-08-01
00879123007643GlideScope®GlideScope® Core™ 10 FHD Premium Configuration0270-1187-FHD2025-08-01

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Primary DI, Brand, Company table
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04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
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04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
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10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
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04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
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04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
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