HemosIL ReadiPlasTin (20 mL)

Basic Information

• Brand Name: HemosIL ReadiPlasTin (20 mL)
• Primary DI: 08426950632887
• Version / Model: 00020301400
• Catalog Number: 00020301400
• 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: 7
• Public Version Date: 2022-11-24
• Public Version Status: Update
• Public Device Record Key: 91c2cf1c-37cb-4ba4-8d4e-1c5fe4023c02

Device Description

HemosIL ReadiPlasTin (20 mL)

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
GJS	TEST, TIME, PROTHROMBIN	Hematology	864.7750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55983	Prothrombin time (PT) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950632887	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122584	000
K213426	000

Storage Conditions

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