FDA.reportPublic FDA data

BCI

Primary DI
15019517042542
Brand
BCI
Company
ICU MEDICAL, INC.
Model
3043
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893877000BIOCHEM 3100 OXIMETERBiochem International, Inc.1989-12-20DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019517042542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951704254215019517042542

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709204192BivonaZT26IS70NSC117N2026-09-25
10887709204451BivonaSZ26IN60NSB136S2026-09-25
10887709204734BivonaSU26IN45NSZ100N2026-09-25
10887709204901BivonaFT26IN60NGF183N2026-09-25
10887709204918BivonaFT26IN35NGA182N2026-09-25
10887709204925BivonaSF26IN80NSC186N2026-09-25
10887709204932BivonaSF26IN80NSC185N2026-09-25
10887709204949BivonaFT26IN35NGE187N2026-09-25
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
00816777025913Sofia 5F-125cm STRMicrovention, Inc.DQO2018-08-07
00816777025920Sofia 5F-115cm STRMicrovention, Inc.DQO2018-08-07
00857688007278Respiguide Delivery SystemRESPICARDIA, INC.DQO2018-04-30
00884450089194EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00884450089200EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00866749000202Morph Universal Deflectable Guide CatheterBIOCARDIA, INC.DQO2016-10-10
08714729200567Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200574Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200598Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24