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Vasomedical™ EZ™ O2 Neonatal Probe (for children under 3 years of age)

FDA UDI

Class II (US FDA UDI)

by Vasomedical, Inc.

Identity

Trade Name
Vasomedical™ EZ™ O2 Neonatal Probe (for children under 3 years of age) FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
EZ™ O2 Neonatal Probe (for children under 3 years of age) FDA UDI
Model / Reference
Model EZ FDA UDI
Description
EZ™ O2 Neonatal Probe (for children under 3 years of age) FDA UDI

Identifiers

Catalog Number
A13-0068 FDA UDI
Primary DI / UDI-DI
00817980021457 FDA UDI
510(k) Number
K063641 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulse oximeter probe, reusable

Vasomedical™ EZ™ O2 Neonatal Probe (for children under 3 years of age) by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K063641 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vasomedical, Inc.

Sources (1)

  • FDA UDI 628f7f58-247a-4356-81cb-27e06ac9c28a 37 fields · synced Jun 8, 2026