Identity
- Trade Name
- Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- The Nox T3 is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The Nox T3 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
- 20012120 FDA UDI
- Description
- The Nox T3 is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The Nox T3 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
- D040200121201 FDA UDI
- 510(k) Number
- K082641 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
Cleared under the same submission
K082641 also covers:
- Care One — Ahold U.S.A., Inc.
- Amazon Basic Care — Amazon.com Services, LLC
- Good Neighbor — Amerisourcebergen Drug Corporation
- Good Neighbor — Amerisourcebergen Drug Corporation
- Pulse oximeter — BETTER BASICS, INC.
- Curaplex — BOUND TREE MEDICAL, LLC
- QUALITY CHOICE — CHAIN DRUG MARKETING ASSOCIATION, INC.
- microdot® — Cambridge Sensors USA, LLC.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Virginia National Guard — Clinical Guard
- CONTEC — Contec Medical Systems Co., Ltd.
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 b6464b8e-5e54-465c-981d-9d8c7ec6cfdd 35 fields · synced May 30, 2026