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Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse Oximeter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- EZ™ O2 P Adult/Pediatric Pulse Oximeter FDA UDI
- Model / Reference
- Model EZ FDA UDI
- Description
- EZ™ O2 P Adult/Pediatric Pulse Oximeter FDA UDI
Identifiers
- Catalog Number
- A13-0002-05-01 FDA UDI
- Primary DI / UDI-DI
- 00817980021419 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulse oximeter
Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse Oximeter by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter.
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- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
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
- MTS — MEDICAL TEST SUPPLY
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vasomedical, Inc.
Sources (1)
- FDA UDI f412b895-eea8-4281-96a4-ecfae0ea4442 37 fields · synced May 30, 2026