DiaSpect Control Pack HBT3

Basic Information

• Brand Name: DiaSpect Control Pack HBT3
• Primary DI: 04048534001571
• Version / Model: 90B.0013
• Company Name: DiaSpect Medical GmbH
• Labeler DUNS: 341050309
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: 81c02996-f3ec-442d-807b-0160c51e9027

Device Description

For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes

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: 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
GGM	Control, Hemoglobin	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55874	Total haemoglobin (totHb) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04048534001724	GS1
Primary	04048534001571	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)