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Compumedics

FDA UDI

Class II (US FDA UDI)

by Compumedics Limited

Identity

Trade Name
Compumedics FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Adult silicone soft tip finger probe-oximeter-1m FDA UDI
Model / Reference
7000-0270-00 FDA UDI
Description
Adult silicone soft tip finger probe-oximeter-1m FDA UDI

Identifiers

Catalog Number
7000-0270-00 FDA UDI
Primary DI / UDI-DI
09342451001467 FDA UDI
510(k) Number
K072201 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 1 Meter FDA UDI

Category: Pulse oximeter probe, reusable

Compumedics by Compumedics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K072201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compumedics Limited

Sources (1)

  • FDA UDI c4417832-aeb0-4aeb-b050-12f0b6ff5c46 38 fields · synced Jun 8, 2026