Coagulation Factor IX Deficient Plasma

Basic Information

• Brand Name: Coagulation Factor IX Deficient Plasma
• Primary DI: 00842768011023
• Version / Model: 10446414
• Catalog Number: OTXX17
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: c51dd097-444b-4d7a-b7e0-5f1d2393ebe9

Device Description

For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods

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: 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
GJT	PLASMA, COAGULATION FACTOR DEFICIENT	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56250	Coagulation factor IX IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor IX in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768011023	GS1
Unit of Use	00842768018824	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K924396	000

Storage Conditions

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