FDA.reportPublic FDA data

BCI

Primary DI
30610586038383
Brand
BCI
Company
ICU MEDICAL, INC.
Model
9048
Published
2020-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970209000CAPNOCHECK PLUSBci Intl., Inc.1997-04-18CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586038383PrimaryGS10
10610586038389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058603838330610586038383
1061058603838910610586038389

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

Regulatory Flags#

DUNS number
118380146
Device count
2
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709198385BivonaXZ26GS70NSC058N2026-08-03
10887709198866BivonaFU26GN40NSZ134N2026-08-03
10887709198880BivonaXU26GS55NGZ141N2026-08-03
10887709199368BivonaZT26GN95ZSZ155N2026-08-03
10887709199580BivonaFT26GN45NSE190N2026-08-03
10887709199641BivonaSA26GN80ZSZ135N2026-08-03
10887709199764BivonaXU26GS60NSA218N2026-08-03
10887709199771BivonaFU26GN55NSF216N2026-08-03
10887709199788BivonaXU26GS60NSA217N2026-08-03
10887709199801BivonaFU25GN65NSD167N2026-08-03
10887709199818BivonaSU26GN50NGF219N2026-08-03
10887709199825BivonaFU26GN45NSC211N2026-08-03
10887709199832BivonaFU26GN45NGF214N2026-08-03
10887709199849BivonaFU26GN35NSE226N2026-08-03
10887709199856BivonaFU26GN30NSE227N2026-08-03
10887709199863BivonaFT26GN40NSC233N2026-08-03
10887709200002BivonaFU26GN45NSF240N2026-08-03
10887709200019BivonaFT26GN55NGF246N2026-08-03
10887709200026BivonaFU26GN30NGA239N2026-08-03
10887709200033BivonaST26GN55NSC245N2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
00607411947124N/ASALTER LABSCCK2026-07-28
00607411947131N/ASALTER LABSCCK2026-07-28
00607411947162N/ASALTER LABSCCK2026-07-28
04048675795124Sample Line 2,5mDrägerwerk AG & Co. KGaACCK2026-07-21
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
00607411919190Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919213Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27