i-STAT PTplus Control Level 2

Basic Information

• Brand Name: i-STAT PTplus Control Level 2
• Primary DI: 00054749004850
• Version / Model: 06P17-18
• Catalog Number: 06P17-18
• Company Name: Abbott Point of Care Inc.
• Labeler DUNS: 116279183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-01-10
• Public Version: 1
• Public Version Date: 2024-01-18
• Public Version Status: New
• Public Device Record Key: 539828e4-0eeb-4a25-83c4-4bdf29d2f1fa

Device Description

For use with i-STAT PTplus cartridges

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: Yes
• 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
55985	Prothrombin time (PT) IVD, control	A material which is used to verify the performance of an assay 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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10054749004857	GS1
Primary	00054749004850	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220282	000

Storage Conditions

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