HemaPrep

Basic Information

• Brand Name: HemaPrep
• Primary DI: 07350040972304
• Version / Model: XU-10012-01
• Company Name: Cellavision AB
• Labeler DUNS: 508663101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-07
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: c3a907f4-56e8-465d-afe8-0f5209da36d9

Device Description

Blood smear instrument

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKJ	Spinner, Slide, Automated	Hematology	864.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62550	Blood smearing manual instrument IVD	A manual laboratory instrument intended to be used to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. The device operates with technician involvement in most procedural steps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350040972304	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]