FDA.reportPublic FDA data

BCI

Primary DI
10610586036347
Brand
BCI
Company
ICU MEDICAL, INC.
Model
3304
Published
2016-10-13
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
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070732000BCI AUTOCON 3304 DIGITAL PULSE OXIMETERSmiths Medical Pm, Inc.2007-07-09DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610586036347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058603634710610586036347

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software; typically it incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709207919BivonaFT26JN30NGF219N2026-10-29
10887709207926BivonaHT26JS70NSC222N2026-10-29
M335400011ICU Medical, INC.400012025-04-28
M335400031ICU Medical, INC.400022025-04-28
10887709207735BivonaHT26JS80NSC205N2026-10-28
10887709207742BivonaFT26JN60NSA203N2026-10-28
10887709207759BivonaST26JN55NSA204N2026-10-28
10887709207766BivonaFT26JN35NGE206N2026-10-28
10887709207773BivonaFP26JN35NSF202N2026-10-28
10887709207780BivonaFT26JN50NGF207N2026-10-28
10887709207797BivonaFT26JN60NSC214N2026-10-28
10887709207803BivonaFT26JN55NGF213N2026-10-28
10887709207810BivonaFT26JN40NSE215N2026-10-28
10887709207827BivonaFT26JN35NGE212N2026-10-28
10887709207834BivonaFT26JN45NGF211N2026-10-28
10887709207841BivonaFT26JN50NGF210N2026-10-28
10887709207858BivonaFT26JN35NGE209N2026-10-28
10887709207865BivonaFT26JN35NGE217N2026-10-28
10887709207872BivonaFT26JN30NGE216N2026-10-28
10887709207285BivonaFU26JN60NGA169N2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725516812APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516829APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516836APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516843APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516850APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516867APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516874APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516881APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516898APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516904APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516911APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516928APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516935APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516942APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516959APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516966APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516973APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516980APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516997APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517000APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517017APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517024APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517031APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517048APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517055APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517062APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517079APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517086APKAPK Technology Co.,Ltd.DQA2026-03-12