DiaSpect Tm 900-001

GUDID 04048534001946

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

• Primary Device ID: 04048534001946
• NIH Device Record Key: 97801091-31ee-404b-8b96-5aba3e078f1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiaSpect Tm
• Version Model Number: 7049-0013-0264
• Catalog Number: 900-001
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048534001946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200520

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: 2021-03-19
• Device Publish Date: 2021-03-11

On-Brand Devices [DiaSpect Tm]

• 04048534001946: For the quantitative determination of hemoglobin in whole blood.
• 04048534002165: For the quantitative determination of hemoglobin in whole blood.