Identity
- Trade Name
- Fingertip Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use and in internist/surgery, Anesthesia, intensive care and etc.). Not for continuously monitoring. FDA UDI
- Model / Reference
- 01MN1000 FDA UDI
- Description
- Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use and in internist/surgery, Anesthesia, intensive care and etc.). Not for continuously monitoring. FDA UDI
Identifiers
- Catalog Number
- 01MN1000 FDA UDI
- Primary DI / UDI-DI
- 07540195054004 FDA UDI
- 510(k) Number
- K070371 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
- 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 28 Gram FDA UDIHeight — 32 Millimeter FDA UDIWidth — 34 Millimeter FDA UDILength — 58 Millimeter FDA UDI
Category: Pulse oximeter probe, reusable
Fingertip Pulse Oximeter by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K070371 also covers:
- AincA® — Anesthesia Associates, Inc.
- AincA® — Anesthesia Associates, Inc.
- Pulse Oximeter — Dynarex Corp.
- Pulse Oximeter — Dynarex Corp.
- ri-fox N, pulse oximeter — Rudolf Riester GmbH & Co. KG
- SPO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor Adapter Cable — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor Adapter Cable — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor Adapter Cable — SUNSET HEALTHCARE SOLUTIONS, Inc.
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
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI aed30418-1752-498e-8e62-deff527ac2b1 38 fields · synced May 31, 2026