EvoEndo Controller

Primary DI
00850031897021
Brand
EvoEndo Controller
Company
Evoendo, Inc.
Model
EE-C
Catalog number
1002
Device description
The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable
Published
2022-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213606000EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.2022-02-14FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850031897021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031897021008500318970218500318970210850031897021

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic control/video-imaging systemA mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117077970
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850031897076Single-Use Gastroscope 3.5/2.0 85cmLE 10212024-08-30
00850031897083Single-Use Gastroscope 3.5/2.0 85cm 5-packLE10252024-08-30
00850031897090Single-Use Gastroscope 3.5/2.0 85cm DEMOLE10272024-08-30
00850031897014EvoEndo Model LE Single-Use GastroscopeLE10012022-02-25
00850031897038EvoEndo Model LE Single-Use GastroscopeLE10052022-02-25

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