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LifeShield Infusion Safety Software Suite

FDA UDI

Class II (US FDA UDI)

by Icu Medical Fleet Services, Llc

Identity

Trade Name
LifeShield Infusion Safety Software Suite FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
GTIN for 17005-02, 1/EA FDA UDI
Model / Reference
17005-02 FDA UDI
Description
GTIN for 17005-02, 1/EA FDA UDI

Identifiers

Primary DI / UDI-DI
00887709127234 FDA UDI
510(k) Number
K242117 FDA UDI
FDA Product Code
PHC FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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

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

LifeShield Infusion Safety Software Suite by Icu Medical Fleet Services, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Cleared under the same submission

K242117 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical Fleet Services, Llc

Sources (1)

  • FDA UDI ed4d4ae8-fff0-4b0d-898e-cffa29e55730 34 fields · synced May 30, 2026