Atellica HEMA HGB 11374307

GUDID 00630414312477

AT HEMA HGB

Siemens Healthcare Diagnostics Inc.

Full blood count IVD, kit, cell count

• Primary Device ID: 00630414312477
• NIH Device Record Key: 731ed843-8af3-40fe-9e94-c9d9c0581bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica HEMA HGB
• Version Model Number: 11374307
• Catalog Number: 11374307
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 4
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414289991 [Primary]
GS1	00630414312477 [Unit of Use]

FDA Product Code

• GGK: PRODUCTS, RED-CELL LYSING PRODUCTS

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: 2026-02-16
• Device Publish Date: 2026-02-06

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414287201 - Atellica HEMA Calibrator: 2026-02-16 AT HEMA Calibrator
• 00630414289694 - Atellica HEMA 580 Analyzer (SMS ready): 2026-02-16 Hematology Analyzer
• 00630414289700 - Atellica HEMA Slidemaker Stainer (SMS): 2026-02-16 Hematology Slide-maker/stainer
• 00630414289953 - Atellica HEMA Diluent: 2026-02-16 AT HEMA Diluent 20L
• 00630414289960 - Atellica HEMA Diluent: 2026-02-16 AT HEMA Diluent
• 00630414312460 - Atellica HEMA Cleaner: 2026-02-16 AT HEMA Cleaner
• 00630414312477 - Atellica HEMA HGB: 2026-02-16AT HEMA HGB
• 00630414312477 - Atellica HEMA HGB: 2026-02-16 AT HEMA HGB
• 00630414290003 - Atellica HEMA Baso: 2026-02-16 Atellica HEMA Baso