Identity
- Trade Name
- MTS FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing, providing fast and accurate oximetry measurements. FDA UDI
- Model / Reference
- OX-400A FDA UDI
- Description
- The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing, providing fast and accurate oximetry measurements. FDA UDI
Identifiers
- Catalog Number
- OX400A FDA UDI
- Primary DI / UDI-DI
- 00869667000415 FDA UDI
- 510(k) Number
- K063641 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter
Mts by Medical Test Supply — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063641 also covers:
- JOHN BUNN — GF Health Products, Inc
- JOHN BUNN — GF Health Products, Inc
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- Pulse Oximeter — Shenzhen Creative Industry Co., Ltd.
- Pulse Oximeter — Shenzhen Creative Industry 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
- Medical Test Supply
Sources (1)
- FDA UDI 78d978a6-ee8d-4084-a7f2-9703976ded75 36 fields · synced Jun 1, 2026