DiaSpect Tm Cuvettes

Basic Information

• Brand Name: DiaSpect Tm Cuvettes
• Primary DI: 14048534001967
• Version / Model: 7049-3013-0369
• Catalog Number: 900-500
• Company Name: EKF-diagnostic GmbH
• Labeler DUNS: 330046442
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2021-03-11
• Public Version: 1
• Public Version Date: 2021-03-19
• Public Version Status: New
• Public Device Record Key: 42cfebd8-8687-45c9-bba6-8a8cfe5f7c66

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

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
Package	24048534001964	GS1	cardboard box	10	In Commercial Distribution
Primary	14048534001967	GS1
Unit of Use	04048534001953	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK200520	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)