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Surveyor S4

FDA UDI

Class II (US FDA UDI)

by Mortara Instrument, Inc.

Identity

Trade Name
Surveyor S4 FDA UDI
Generic Name
Electrocardiography telemetric monitoring system transmitter FDA UDI
Device Name
Electrocardiographic telemetry monitoring system transmitter FDA UDI
Model / Reference
S4-Q-BSX-XXX FDA UDI
Description
Electrocardiographic telemetry monitoring system transmitter FDA UDI

Identifiers

Primary DI / UDI-DI
00812345027853 FDA UDI
510(k) Number
K141020 FDA UDI
K160685 FDA UDI
FDA Product Code
MHX FDA UDI
DRG FDA UDI
GMDN Term
Electrocardiography telemetric monitoring system transmitter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
870.2910 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiography telemetric monitoring system transmitter

Surveyor S4 by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiography telemetric monitoring system transmitter.

Cleared under the same submission

K141020 also covers:

K160685 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mortara Instrument, Inc.

Sources (1)

  • FDA UDI 0ce1cb3c-16f2-46f9-ad80-72c3654333ca 36 fields · synced May 30, 2026