HemosIL Factor II Deficient Plasma (10 X 1 mL)

Basic Information

• Brand Name: HemosIL Factor II Deficient Plasma (10 X 1 mL)
• Primary DI: 08426950484738
• Version / Model: 00020012200
• Catalog Number: 00020012200
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: 924d620b-9d9b-4f4a-98b7-75026cdcbfc9

Device Description

HemosIL Factor II Deficient Plasma (10 X 1 mL)

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
GJT	PLASMA, COAGULATION FACTOR DEFICIENT	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56003	Coagulation factor II (prothrombin) 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 II (prothrombin) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950484738	GS1
Unit of Use	18426950484735	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050661	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Unopened deficient plasma is stable until the expiration date shown on the vial when stored at 2-8°C.