HemoScreen

Basic Information

• Brand Name: HemoScreen
• Primary DI: 07290016991048
• Version / Model: CBC Sampler
• Catalog Number: BC-FA-00201
• Company Name: PIXCELL MEDICAL TECHNOLOGIES LTD
• Labeler DUNS: 532623092
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 6
• Public Version Date: 2022-09-30
• Public Version Status: Update
• Public Device Record Key: 95c45829-a81b-4810-909b-9e41479e0f82
• Distribution End Date: 2022-09-30

Device Description

A disposable unit used for the collection of the blood sample

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
57892	Capillary blood collection tube IVD, K2EDTA	A non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016991048	GS1
Unit of Use	07290016991031	GS1
Package	17290016991038	GS1	Carton box	10	Not in Commercial Distribution	2022-09-30
Package	27290016991035	GS1	Carton box	100	Not in Commercial Distribution	2022-09-30

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