Telserve® Data Management System

FDA UDI

Class I (US FDA UDI)

by Telcare, Llc

Identity

Trade Name: Telserve® Data Management System FDA UDI
Generic Name: Self-care monitoring/reporting software FDA UDI
Device Name: The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. FDA UDI
Model / Reference: DMS FDA UDI
Description: The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. FDA UDI

Identifiers

Primary DI / UDI-DI: 00859519002247 FDA UDI
510(k) Number: K110571 FDA UDI
FDA Product Code: JQP FDA UDI
GMDN Term: Self-care monitoring/reporting software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Self-care monitoring/reporting software

Telserve® Data Management System by Telcare, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K110571 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Telcare, Llc

Sources (1)

FDA UDI 92b47afb-4d9a-42e5-9989-f23c636675f4 35 fields · synced May 30, 2026