Identity
- Trade Name
- Unimed FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Reusable SpO2 Sensor/Nihon Kohden/Soft Tip/Adult/1.5M/DB9M/SORIMEX FDA UDI
- Model / Reference
- SWSD15-16 FDA UDI
- Description
- Reusable SpO2 Sensor/Nihon Kohden/Soft Tip/Adult/1.5M/DB9M/SORIMEX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945664821285 FDA UDI
- 510(k) Number
- K142832 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter probe, reusable
Unimed by Unimed Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142832 also covers:
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, Inc.
- Unimed — Unimed Medical Supplies, 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
- Unimed Medical Supplies, Inc.
Sources (1)
- FDA UDI b1f5b337-cbe3-4ec2-b135-7da2ee538d25 34 fields · synced Jun 1, 2026