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ASSURE Assist Service

FDA UDI

Class I (US FDA UDI)

by Kestra Medical Technologies, Inc.

Identity

Trade Name
ASSURE Assist Service FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occurrence of a triggering event. FDA UDI
Model / Reference
80739-001 FDA UDI
Description
The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occurrence of a triggering event. FDA UDI

Identifiers

Catalog Number
80739-001 FDA UDI
Primary DI / UDI-DI
00840241600344 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment clinical data interfacing software

ASSURE Assist Service by Kestra Medical Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kestra Medical Technologies, Inc.

Sources (1)

  • FDA UDI 5ef0e56e-03f3-4720-b420-9fc35ed49fc0 34 fields · synced Jun 9, 2026