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Mindray

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Mindray FDA UDI
Generic Name
Electronic oesophageal stethoscope, reusable FDA UDI
Model / Reference
0206-03-0300-02 FDA UDI

Identifiers

Primary DI / UDI-DI
10610674804902 FDA UDI
510(k) Number
K864195 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Electronic oesophageal stethoscope, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Category: Electronic oesophageal stethoscope, reusable

Mindray by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electronic oesophageal stethoscope, reusable.

Cleared under the same submission

K864195 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 98f782e3-e49e-4ed0-9c1b-c1f10f801d10 33 fields · synced Jun 6, 2026