EKF Link 0760-0101

GUDID 04048534002011

EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes. EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link. EKF Link facilitates the setting of configurable options of connected analyzers.

EKF-diagnostic GmbH

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 04048534002011
• NIH Device Record Key: 57339f1f-fd6e-4c38-b453-7f6fcedd149f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKF Link
• Version Model Number: 0760-0101
• Catalog Number: 0760-0101
• Company DUNS: 330046442
• Company Name: EKF-diagnostic GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048534002011 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-25
• Device Publish Date: 2021-10-15

Devices Manufactured by EKF-diagnostic GmbH

• 04048534002165 - DiaSpect Tm: 2022-10-25 For the quantitative determination of hemoglobin in whole blood.
• 04048534002011 - EKF Link: 2021-10-25EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes. EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link. EKF Link facilitates the setting of configurable options of connected analyzers.
• 04048534002011 - EKF Link: 2021-10-25 EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display mea
• 04048534002035 - Hemo Control Hemoglobin Microcuvette: 2021-05-18 For the quantitative determination of hemoglobin in whole blood.
• 04048534002028 - Hemo Control: 2021-05-18 For the quantitative determination of hemoglobin in whole blood.
• 04048534002004 - DiaSpect Control HBT4: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001977 - DiaSpect Control HBT1: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001984 - DiaSpect Control HBT2: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001991 - DiaSpect Control HBT3: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes