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Vasomedical™ EZ™ Software CD and Data Cable for Wrist Pulse Oximeter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Vasomedical™ EZ™ Software CD and Data Cable for Wrist Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- EZ™ Software CD and Data Cable for Wrist Pulse Oximeter FDA UDI
- Model / Reference
- Model EZ FDA UDI
- Description
- EZ™ Software CD and Data Cable for Wrist Pulse Oximeter FDA UDI
Identifiers
- Catalog Number
- A13-0041 FDA UDI
- Primary DI / UDI-DI
- 00817980021440 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
No
FDA UDI
Category: Pulse oximeter
Vasomedical™ EZ™ Software CD and Data Cable for Wrist Pulse Oximeter by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Pulse oximeter.
- Nonin — Nonin Medical, Inc. · Class II
- acurio — XIAMEN ACURIO INSTRUMENT CO., LTD · Class II
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- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- Andesfit — ANDESFIT LIMITED · Class II
- 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 |
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Manufacturer
- Manufacturer
- Vasomedical, Inc.
Sources (1)
- FDA UDI f55be703-fe00-4b6a-93ad-8c10e6317159 37 fields · synced May 30, 2026