bkSpecto Ultrasound System 1300

GUDID 05704916001285

The 1300 Ultrasound Scanner is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mec

Bk Medical ApS

General-purpose ultrasound imaging system
Primary Device ID05704916001285
NIH Device Record Key81d568ae-0ce3-4c5a-9668-68d6654ea811
Commercial Distribution StatusIn Commercial Distribution
Brand NamebkSpecto Ultrasound System
Version Model Number1300
Catalog Number1300
Company DUNS310093901
Company NameBk Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105704916001285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-13
Device Publish Date2018-07-12

Devices Manufactured by Bk Medical ApS

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05704916001667 - Non-implantable needle guide, single-use2022-12-15 Disposable 18g Transperineal Needle Guide
05704916001698 - Non-implantable needle guide, single-use2022-12-15 Non-implantable needle guide, single-use
05704916001599 - Rob12C42022-05-31 The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted p
05704916000240 - I13C3f Transducer2020-04-03 Intraoperative
05704916001131 - N20P6 Transducer2020-04-03 High resolution, mini footprint, Intraoperative (neuro) imaging
05704916001315 - I12C5 transducer2020-04-03 Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)
05704916001407 - Non-implantable, needle guide, reusable2019-12-23 Reusable Transperineal Needle Guide

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