wtATTR-CM AcceleraTTR™

GUDID 05415062388310

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

PFIZER INC.

Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software Cardiovascular risk/probability assessment interpretive software

• Primary Device ID: 05415062388310
• NIH Device Record Key: 368e1cba-f4da-46fe-baa7-eb72c69e3d42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: wtATTR-CM AcceleraTTR™
• Version Model Number: CI4054279
• Company DUNS: 829076566
• Company Name: PFIZER INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com
• Phone: +1(484)865-6166
• Email: UDICompliance@pfizer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415062388310 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, for clinical use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-08
• Device Publish Date: 2022-07-29

Devices Manufactured by PFIZER INC.

• 05415062388310 - wtATTR-CM AcceleraTTR™: 2022-08-08Software to identify heart failure patients who may be at risk of having wtATTR-CM
• 05415062388310 - wtATTR-CM AcceleraTTR™: 2022-08-08 Software to identify heart failure patients who may be at risk of having wtATTR-CM
• 00305733010020 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP S/M 8HR 2CT
• 00305733010037 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 2CT
• 00305733010075 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT
• 00305733010389 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT
• 00305733010396 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT
• 00305733010969 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT
• 00305733010983 - ThermaCare HeatWraps: 2020-06-08 THERMACARE LOWER BACK & HIP 8CT + NECK/SHOULDER/WRIST 1CT