HemoScreen

GUDID 07290016991000

The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic point-of-care (POC) use to classify and enumerate the following parameters for capillary and venous whole blood (K2 EDTA anticoagulated) in adults and children at least 2 years of age: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV NEUT%, NEUT#, LYMPH%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen analyzer is indicated for use in clinical laboratories, and in POC settings

PIXCELL MEDICAL TECHNOLOGIES LTD

Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 07290016991000
• NIH Device Record Key: bbe1d947-a863-4aac-93d2-9253218ddead
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoScreen
• Version Model Number: HemoScreen 200
• Company DUNS: 532623092
• Company Name: PIXCELL MEDICAL TECHNOLOGIES LTD
• 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: true
• 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: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com
• Phone: +97249593516
• Email: info@pixcell-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016991000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180020

FDA Product Code

• GKZ: Counter, Differential Cell

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: 2019-12-23
• Device Publish Date: 2019-01-14

On-Brand Devices [HemoScreen]

• 07290016991048: A disposable unit used for the collection of the blood sample
• 07290016991024: A self-contained disposable unit in which a single blood sample is prepared and made ready for m
• 07290016991000: The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic
• 17290016991076: A disposable unit used for the collection of the blood sample