FDA UDI
In Commercial Distribution
🇺🇸 United States
EMAY
DI: 04897087200098
·
Model: SleepO2 Pro
·
EMAY (HK) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EMAY
- Primary DI
- 04897087200098
- Version / Model
- SleepO2 Pro
- Company Name
- EMAY (HK) LIMITED
- Labeler DUNS
- 664020405
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-18
- Public Version
- 1
- Public Version Date
- 2024-01-26
- Public Version Status
- New
- Public Device Record Key
- 194f6087-bacd-4076-8ff1-f035c7a4220c
- Distribution End Date
- 2030-12-31
Device Description
The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 45607 | Pulse oximeter | An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04897087200098 | GS1 |