Calibration Plasma LMW Heparin

Basic Information

• Brand Name: Calibration Plasma LMW Heparin
• Primary DI: 08426950088974
• Version / Model: 82 3500 63
• Catalog Number: 82 3500 63
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: a203ef98-3d46-40ca-a92b-554d2708e2fa

Device Description

Calibration Plasma LMW Heparin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JIS	CALIBRATOR, PRIMARY	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56196	Heparin anti-Xa IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950088974	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030964	000

Storage Conditions

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