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 |