Vasomedical™ EZ™ O2 Wrist Pulse Oximeter A13-0002-02-01
GUDID 00817980021433
EZ™ O2 Wrist Pulse Oximeter
VASOMEDICAL, INC.
Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter| Primary Device ID | 00817980021433 |
| NIH Device Record Key | 3482b514-88b7-477f-9ebc-f403b88c9367 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vasomedical™ EZ™ O2 Wrist Pulse Oximeter |
| Version Model Number | Model EZ |
| Catalog Number | A13-0002-02-01 |
| Company DUNS | 197210248 |
| Company Name | VASOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817980021433 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063641
FDA Product Code
| DQA | Oximeter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-29 |
Devices Manufactured by VASOMEDICAL, INC.
| 00817980020009 - Vasomedical-Biox™ 1305 3 Channel ECG Holter Recorder | 2019-11-08 3 CH ECG Holter Recorder |
| 00817980020016 - Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder | 2019-11-08 3 CH ECG Holter ULTRA Recorder |
| 00817980020023 - Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder | 2019-11-08 12 CH ECG Holter Recorder |
| 00817980020030 - Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder | 2019-11-08 12 CH ECG Holter Ultra Recorder |
| 00817980020047 - Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W | 2019-11-08 Ambulatory Blood Pressure Recorder |
| 00817980020054 - Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W | 2019-11-08 Ambulatory Blood Pressure Recorder |
| 00817980020061 - Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth | 2019-11-08 Ambulatory Blood Pressure Recorder w/Bluetooth |
| 00817980020078 - Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor | 2019-11-08 3 CH ECG Holter/ABP COMBINED Recorder |
Trademark Results [Vasomedical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VASOMEDICAL 98473500 not registered Live/Pending |
Vasomedical, Inc. 2024-03-28 |
 VASOMEDICAL 87853168 5570675 Live/Registered |
Vasomedical, Inc. 2018-03-28 |
 VASOMEDICAL 85056076 3904391 Dead/Cancelled |
Vasomedical, Inc. 2010-06-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.