Primary Device ID | 00073796842314 |
NIH Device Record Key | 0440a2f8-0742-464e-9aa5-be6cfa017b85 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Extra Large D-ring Cuff, Telehealth, Blood Pressure Monitor |
Version Model Number | HEM-RXL31 |
Company DUNS | 054318779 |
Company Name | Omron Healthcare, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Phone | 1-800-634-4350 |
ohiquality@omron.com |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00073796842314 [Primary] |
GS1 | 10073796842311 [Package] Package: Case [10 Units] In Commercial Distribution |
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-07-22 |
Device Publish Date | 2017-04-26 |
10073796271500 - 3 Series Upper Arm Blood Pressure Monitor | 2024-04-23 Automatic inflation upper arm blood pressure monitor with wide range cuff. (9-17 inch), Bluetooth connectivity, 14 memory storag |
10073796272552 - Omron 5 Series Upper Arm Blood Pressure Monitor | 2024-04-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Memory Storage, Extra Large Display, Irregular Heartbeat Detection |
10073796423121 - Extra large D-ring Cuff for Telehealth Blood Pressure Monitor | 2022-08-09 |
10073796893108 - Blood Pressure Monitor | 2022-07-11 Telehealth Blood Pressure Monitor with extra large cuff compatibility. |
00073796930004 - Blood Pressure Monitor | 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch. |
10073796711020 - Omron Upper Arm Blood Pressure Monitor | 2021-09-23 Upper arm blood pressure monitor - One-touch operation - 30 memory storage - irregular heartbeat detection |
00073796507206 - No-Touch Forehead Thermometer | 2021-09-09 No-touch forehead thermometer with fast 1 second measurement and high temperature notification. 25 memory reading. |
00073796745530 - Omron Blood Pressure Monitor | 2021-09-09 Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory stor |