ICU Medical, Inc.

GUDID 10887709127354

GTIN for B33984, 1/EA

ICU MEDICAL, INC.

Fluid transfer set, general-purpose
Primary Device ID10887709127354
NIH Device Record Key1b9a9b85-13ce-4754-9ce8-c9564c02a2ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameICU Medical, Inc.
Version Model NumberB33984
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100887709127357 [Primary]
GS110887709127354 [Package]
Contains: 00887709127357
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMGStopcock, i.V. Set

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

On-Brand Devices [ICU Medical, Inc.]

10887709128078GTIN for B2229, 92" (234 cm) Appx 10.4 ml 15 Drop Admin Set w/5.0 Micron Filter, Inj Site, Spin
10887709127361GTIN for MC330716, 1/EA
10887709127354GTIN for B33984, 1/EA

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