HemoScreen

Basic Information

• Brand Name: HemoScreen
• Primary DI: 07290016991017
• Version / Model: CBC Cartridge
• Catalog Number: BC-FA-00103
• Company Name: PIXCELL MEDICAL TECHNOLOGIES LTD
• Labeler DUNS: 532623092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 4
• Public Version Date: 2022-01-28
• Public Version Status: Update
• Public Device Record Key: e8b7fa4f-040d-4d7c-b822-7929bd514eef

Device Description

A self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKZ	Counter, Differential Cell	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55854	Full blood count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07290016991024	GS1	Carton box	10	In Commercial Distribution
Primary	07290016991017	GS1
Package	17290016991014	GS1	Carton box	10	In Commercial Distribution
Package	27290016991011	GS1	Carton box	25	In Commercial Distribution
Package	37290016991018	GS1	Carton box	100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180020	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 17 – 27 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 17 – 27 Degrees Celsius