Hemo Control 3040-0010-0218

GUDID 04048534002028

For the quantitative determination of hemoglobin in whole blood.

EKF-diagnostic GmbH

Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care

• Primary Device ID: 04048534002028
• NIH Device Record Key: 895ec5f8-7c57-40fa-bd87-d64043014949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemo Control
• Version Model Number: 3040-0010-0218
• Catalog Number: 3040-0010-0218
• Company DUNS: 330046442
• Company Name: EKF-diagnostic GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048534002028 [Primary]

FDA Product Code

• GKR: System, Hemoglobin, Automated

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: 2021-05-18
• Device Publish Date: 2021-05-10

Devices Manufactured by EKF-diagnostic GmbH

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• 04048534002035 - Hemo Control Hemoglobin Microcuvette: 2021-05-18 For the quantitative determination of hemoglobin in whole blood.
• 04048534002028 - Hemo Control: 2021-05-18For 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