Medfusion

GUDID 10610586031823

ICU MEDICAL, INC.

Suction system filter, microbial
Primary Device ID10610586031823
NIH Device Record Keydd865a58-ae66-47d8-9a2a-ad7a988f37c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedfusion
Version Model Number3000CAL
Company DUNS118380146
Company NameICU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110610586031823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2025-04-16
Device Publish Date2016-11-16

Devices Manufactured by ICU MEDICAL, INC.

10887709168241 - Bivona2025-09-03 FU25HN60NGC218N Bivona DI: Non-Adjustable-Wired_Non-Sterile
10887709168258 - Bivona2025-09-03 FT25HN30NGA219N Bivona DI: Non-Adjustable-Wired_Non-Sterile
10887709168067 - Bivona2025-09-02 SU25HN50NGF204N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
10887709168074 - Bivona2025-09-02 HU25HS70NSC205N Bivona DI: Non-Adjustable-Wired_Non-Sterile
10887709168081 - Bivona2025-09-02 XT25HS40NGA206N Bivona DI: Non-Adjustable-Wired_Non-Sterile
10887709168098 - Bivona2025-09-02 XT25HS35NGA207N Bivona DI: Non-Adjustable-Wired_Non-Sterile
10887709168159 - Bivona2025-09-02 FU25HN60NGF209N Bivona DI: Non-Adjustable-Wired_Non-Sterile
10887709168166 - Bivona2025-09-02 HT25HS55NSC210N Bivona DI: Non-Adjustable-Wired_Non-Sterile

Trademark Results [Medfusion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDFUSION
MEDFUSION
77652053 3647529 Live/Registered
Smiths Medical ASD, Inc.
2009-01-19
MEDFUSION
MEDFUSION
76176302 2509799 Live/Registered
NXGN MANAGEMENT, LLC
2000-12-06
MEDFUSION
MEDFUSION
74474496 not registered Dead/Abandoned
Medex, Inc.
1993-12-27

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