i-STAT PTplus Cartridge

Basic Information

• Brand Name: i-STAT PTplus Cartridge
• Primary DI: 00054749004782
• Version / Model: 03P89-50
• Catalog Number: 03P89-50
• Company Name: Abbott Point of Care Inc.
• Labeler DUNS: 116279183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• 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: 2f4239d6-24ac-4668-9bd6-1e3d7769a1b2

Device Description

For the determination of prothrombin time.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: Yes
• 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
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
Unit of Use	10054749004789	GS1
Primary	00054749004782	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