| 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 |