FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Fingertip Pulse Oximeter
DI: 00850253007116
·
Model: EHP50D1
·
EASY HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Easy@Home Fingertip Pulse Oximeter
- Primary DI
- 00850253007116
- Version / Model
- EHP50D1
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 5
- Public Version Date
- 2019-06-14
- Public Version Status
- Update
- Public Device Record Key
- 3eeab0d5-7117-406c-985f-1c863889da82
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCH | Oximeter, Infrared, Sporting, Aviation | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17667 | Telemetric pulse oximeter | A portable, photoelectric device intended for the transcutaneous monitoring of haemoglobin oxygen saturation (SpO2) through the radio transmission/reception of SpO2 values. 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) which are radio transmitted to a monitoring site to obviate the need for cabling, promoting the patient's freedom of movement. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850253007116 | GS1 | ||||
| Package | 10850253007113 | GS1 | 200 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082641 | 000 |