| 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 | 
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 | 
| UDICompliance@pfizer.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05415062388310 [Primary] | 
| JQP | Calculator/data processing module, for clinical use | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-08-08 | 
| Device Publish Date | 2022-07-29 | 
| 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 |