Identity
- Trade Name
- Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- The GEM is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The GEM is designed to assess the functioning of the airway using SPO2 and variations in heart rate to measure how well the airway is functioning. The Oximeter measures the blood oxygen level and heart rate then transmits the data to the Galaxy Tablet for storage and processing FDA UDI
- Model / Reference
- 20012150 FDA UDI
- Description
- The GEM is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The GEM is designed to assess the functioning of the airway using SPO2 and variations in heart rate to measure how well the airway is functioning. The Oximeter measures the blood oxygen level and heart rate then transmits the data to the Galaxy Tablet for storage and processing FDA UDI
Identifiers
- Primary DI / UDI-DI
- D040200121501 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pulse Oximeter by Whip-Mix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Whip-Mix Corp.
Sources (1)
- FDA UDI 41b61d79-27ff-4f09-8efb-b4401d3d4af2 34 fields · synced May 30, 2026