| Primary Device ID | 06972480913061 |
| NIH Device Record Key | a5920470-5c17-4e39-ab6e-1ae9d013b6ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AILE fingertip pulse oximeter |
| Version Model Number | W011 |
| Company DUNS | 554530454 |
| Company Name | Jiangxi Aicare Medical Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972480913061 [Primary] |
| OCH | Oximeter, Infrared, Sporting, Aviation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-10 |
| Device Publish Date | 2023-04-01 |
| 06972480913269 - COOCEER Electronic Sphygmomanometers | 2023-09-08 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |
| 06972480913061 - AILE fingertip pulse oximeter | 2023-04-10The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate. This device is not a medical device and is not intended to diagnose and/or treat any medical condition or disease. This device is for Sports and Aviation use only and not for medical use. |
| 06972480913061 - AILE fingertip pulse oximeter | 2023-04-10 The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate. This devi |
| 06972480912996 - AILE Electronic Sphygmomanometers | 2023-03-13 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |
| 06972480913009 - AILE Electronic Sphygmomanometers | 2023-03-13 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |
| 06972480913023 - AILE Electronic Sphygmomanometers | 2023-03-13 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |
| 06972480913030 - AILE Electronic Sphygmomanometers | 2023-03-13 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |
| 06972480913047 - AILE Electronic Sphygmomanometers | 2023-03-13 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |
| 06972480913054 - AILE Electronic Sphygmomanometers | 2023-03-13 Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult |