C-Chip

Basic Information

• Brand Name: C-Chip
• Primary DI: 08809317540696
• Version / Model: DHC-B0420
• Catalog Number: DHC-B0420
• Company Name: NanoEnTek, Inc.
• Labeler DUNS: 687910463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-25
• Public Version: 1
• Public Version Date: 2019-07-03
• Public Version Status: New
• Public Device Record Key: dd535bb8-52d4-45a0-b314-fdf22547c5d4

Device Description

The DHC-B0420 grid pattern is exactly same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GHO	Hemocytometer	Hematology	864.6160	1

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
Primary	08809317540696	GS1