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ECG Module Kit(AHA)

FDA UDI

Class II (US FDA UDI)

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name
ECG Module Kit(AHA) FDA UDI
Generic Name
Patient monitoring system module, electrocardiographic FDA UDI
Model / Reference
115-024659-00 FDA UDI

Identifiers

Primary DI / UDI-DI
06944904053097 FDA UDI
510(k) Number
K150204 FDA UDI
FDA Product Code
IYN FDA UDI
GMDN Term
Patient monitoring system module, electrocardiographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 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: Patient monitoring system module, electrocardiographic

ECG Module Kit(AHA) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electrocardiographic.

Cleared under the same submission

K150204 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co.

Sources (1)

  • FDA UDI 08ed2103-6b5c-42d4-b23b-bee127cda4bb 34 fields · synced Jun 8, 2026