Dade Ci-Trol Coagulation Control Level 1

Basic Information

• Brand Name: Dade Ci-Trol Coagulation Control Level 1
• Primary DI: 00630414640167
• Version / Model: 10873842
• Catalog Number: 10873842
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2024-03-25
• Public Version: 1
• Public Version Date: 2024-04-02
• Public Version Status: New
• Public Device Record Key: f37d87dc-9243-4a2a-8762-1276349bdaec

Device Description

For use as control in citrated coagulation systems

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
GGC	Control, plasma, abnormal	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor 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 one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00842768019470	GS1
Primary	00630414640167	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius