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
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04580826921070PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921117PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921148PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922473PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922497PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925979PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
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07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16