CVS Health
- Primary DI
- 00050428504666
- Brand
- CVS Health
- Company
- WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Model
- OX200
- Device description
- Relaxation Coach Pulse Oximeter
- Published
- 2019-10-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| PGJ | Oximeter, Wellness |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PGJ | Oximeter, Wellness | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10050428504663 | Package | GS1 | 48 | In Commercial Distribution |
| 00050428504666 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10050428504663 | 10050428504663 | | |
| 00050428504666 | 00050428504666 | 050428504666 | 0050428504666 |
GMDN Terms
| Term | Definition |
|---|
| Pulse oximeter, battery-powered | A portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 0 Percent (%) Relative Humidity | 93 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -13 Degrees Fahrenheit | 158 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 062312574
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00093764604133 | A&D Medical | A&D COMPANY, LIMITED | PGJ | 2024-02-15 |
| 10311917044504 | Walgreens | WALGREEN CO. | PGJ | 2023-12-18 |
| 06927394500999 | Accare® | Hunan Accurate Bio-Medical Technology Co., Ltd. | PGJ | 2023-11-06 |
| 00050428440865 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | PGJ | 2023-06-05 |
| 00050428458983 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | PGJ | 2023-06-05 |
| 00860010157008 | Algo SaMD | All.health, Inc. | PGJ | 2023-06-02 |
| 10810110200132 | Beurer | BEURER NORTH AMERICA, L.P. | PGJ | 2023-04-17 |
| 06927394501583 | Accurate® | Hunan Accurate Bio-Medical Technology Co., Ltd. | PGJ | 2023-03-13 |
| 00840295400440 | Therabody | Theragun, Inc | PGJ | 2022-08-03 |
| 06942820462146 | Choicemmed | Beijing Choice Electronic Technology Co., Ltd. | PGJ | 2022-02-10 |
| 00850018808088 | Vitalcontrol | BEURER NORTH AMERICA, L.P. | PGJ | 2021-08-30 |
| 04055334330404 | Silvercrest | LIDL US, LLC | PGJ | 2021-08-30 |