HemoPoint H2 DMS

Basic Information

• Brand Name: HemoPoint H2 DMS
• Primary DI: 00657498000199
• Version / Model: G3500-001
• Catalog Number: G3500-001
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-01-01
• Public Version Status: Update
• Public Device Record Key: e767be52-0f80-4f18-aff7-a163c13a6636
• Distribution End Date: 2020-01-01

Device Description

The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.

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: No
• 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
GKR	System, Hemoglobin, Automated	Hematology	864.5620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32435	Haemoglobin analyser IVD, point-of-care	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00657498000199	GS1

Customer Contacts

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