FDA.reportPublic FDA data

VISIONAIR

Primary DI
00860009626805
Brand
VISIONAIR
Company
PACIFICMD BIOTECH, LLC
Model
2
Device description
The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BXQRhinoanemometer (Measurement Of Nasal Decongestion)
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXQRhinoanemometer (Measurement Of Nasal Decongestion)Anesthesiology2
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221892000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221892000VISIONAIRPacificmd Biotech, LLC2022-10-05BXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009626805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009626805008600096268058600096268050860009626805

GMDN Terms#

Term, Definition table
TermDefinition
Computerized rhinomanometerAn electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will typically be line-powered (AC-powered) or powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093528241
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04953170467592DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EOB2024-11-14
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546368Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546375Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546382Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546399Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546405Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546412Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546429Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546436Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546443Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546481Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546191Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22