wtATTR-CM AcceleraTTR™

Basic Information

• Brand Name: wtATTR-CM AcceleraTTR™
• Primary DI: 05415062388310
• Version / Model: CI4054279
• Company Name: PFIZER INC.
• Labeler DUNS: 829076566
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-29
• Public Version: 1
• Public Version Date: 2022-08-08
• Public Version Status: New
• Public Device Record Key: 368e1cba-f4da-46fe-baa7-eb72c69e3d42

Device Description

Software to identify heart failure patients who may be at risk of having wtATTR-CM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQP	Calculator/data processing module, for clinical use	Clinical Chemistry	862.2100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64918	Cardiovascular risk/probability assessment interpretive software	An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization). It typically combines some of the following data: patient demographics, physical measurements, symptoms, medical history, results of the qualitative/quantitative clinical specimen in vitro diagnostic (IVD) tests. It typically creates a risk score or probability that may be used to guide patient management. This software is not an IVD device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415062388310	GS1

Customer Contacts

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