FDA.reportPublic FDA data

Screeni

Primary DI
03664977030032
Brand
Screeni
Company
AXESS VISION TECHNOLOGY
Model
30030001
Catalog number
30030001
Device description
Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display live imaging data captured by sterile disposable endoscopes (Broncoflex Agile or Vortex).
Published
2020-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K202180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202180000Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001Axess Vision Technology2020-10-22EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664977030032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664977030032036649770300323664977030032

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useA sterile 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 commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth110Millimeter
Height200Millimeter
Length300Millimeter
Weight1.8Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
285985615
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664977000103Broncoflex XFlo100400012025-07-18
03664977000042Easy BAL Clip™41010000410100002023-07-28
03664977000011Easy BAL Clip™41010000410100002023-07-28
03664977010034Broncoflex Vortex10030001100300012020-12-10
03664977020033Broncoflex Agile20030001200300012020-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972084140634WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28