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Irrigation Set

FDA UDI

Class I (US FDA UDI)

by Icu Medical Fleet Services, Llc

Identity

Trade Name
Irrigation Set FDA UDI
Generic Name
Single-administration urethral drainage/irrigation catheter FDA UDI
Device Name
LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Container Irrigation Systems (previously Hospira product) FDA UDI
Model / Reference
654101 FDA UDI
Description
LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Container Irrigation Systems (previously Hospira product) FDA UDI

Identifiers

Catalog Number
0654101 FDA UDI
Primary DI / UDI-DI
10887787006701 FDA UDI
FDA Product Code
GBX FDA UDI
GMDN Term
Single-administration urethral drainage/irrigation catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 26 Inch FDA UDI

Category: Single-administration urethral drainage/irrigation catheter

Irrigation Set by Icu Medical Fleet Services, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-administration urethral drainage/irrigation catheter.

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 478c773b-de91-4432-9786-8f0cee7327a6 37 fields · synced Jun 8, 2026