HemaPrep

GUDID 07350040972304

Blood smear instrument

Cellavision AB

Blood smear instrument IVD, manual

• Primary Device ID: 07350040972304
• NIH Device Record Key: c3a907f4-56e8-465d-afe8-0f5209da36d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemaPrep
• Version Model Number: XU-10012-01
• Company DUNS: 508663101
• Company Name: Cellavision AB
• 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: 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: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se
• Phone: +46464601600
• Email: service@cellavision.se

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350040972304 [Primary]

FDA Product Code

• GKJ: Spinner, Slide, Automated

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-12
• Device Publish Date: 2018-11-07

Devices Manufactured by Cellavision AB

• 07350040975091 - CellaVision DC-1: 2020-10-30
• 07350040975107 - CellaVision DC-1 PPA: 2020-10-30
• 07350040970201 - CellaVision® DM96: 2019-04-12 Automated cell locating device. DM96 automatically locates and presents images of blood cells on peripherall blood smears.
• 07350040971277 - CellaVision® DM1200: 2019-04-12 Automated cell locating device. DM1200 automatically locates and presents images of blood cells on peripherall blood smears.
• 07350040972021 - Automated Digital Morphology Analyzer DI-60: 2019-04-12 Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears
• 07350040972304 - HemaPrep: 2019-04-12Blood smear instrument
• 07350040972304 - HemaPrep: 2019-04-12 Blood smear instrument
• 07350040972557 - CellaVision® Body Fluid Application DM1200: 2019-04-12 The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
• 07350040972564 - CellaVision® Body Fluid Application DM96: 2019-04-12 The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.