Hemo Control Hemoglobin Microcuvette

Basic Information

• Brand Name: Hemo Control Hemoglobin Microcuvette
• Primary DI: 04048534000031
• Version / Model: 3000-3012-0765
• Catalog Number: 3000-3012-0765
• Company Name: EKF-diagnostic GmbH
• Labeler DUNS: 330046442
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-05-10
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: e295f6ab-3838-430a-a71b-1a84346d217c

Device Description

For the quantitative determination of hemoglobin in whole blood.

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: 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
GKR	System, Hemoglobin, Automated	Hematology	864.5620	2
KHG	Whole Blood Hemoglobin Determination	Hematology	864.7500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55872	Total haemoglobin (totHb) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total haemoglobin (totHb) in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04048534002035	GS1
Primary	04048534000031	GS1

Customer Contacts

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