BCI

GUDID 10610586036873

ICU MEDICAL, INC.

Carbon dioxide monitor
Primary Device ID10610586036873
NIH Device Record Key21a0cd02-07b2-44ed-a3e4-2df223af1fda
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model Number9004051
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS110610586036873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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 Date2016-10-13

On-Brand Devices [BCI]

1061058604068921-0470-0105-24
106105860383346120LA
106105860381439212A
1061058603809992M774325A
1061058603808292M774325
10610586037399920654335A
10610586037368920654235A
10610586037344920654230A
10610586037313920654220A
106105860368739004051
106105860368669004050
106105860368599004007
106105860368429004005
106105860368359004002
106105860368289004001
106105860368119004000
106105860367368400D
106105860366066004006
106105860365906004004
106105860365836004001
106105860365766004000
106105860365213304LS
106105860364159004003
106105860363789212S
084266381706876120N
084266381706636120SA
084266381706566120C
084266381706496120SC
084266381631086120A

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