FDA.reportPublic FDA data

MEDFUSION

Primary DI
15019517155150
Brand
MEDFUSION
Company
ICU MEDICAL, INC.
Model
67-2450-010700-01
Published
2019-09-20
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
FRNPump, infusion
MRZACCESSORIES, PUMP, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111386000MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc.2011-08-29FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019517155150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951715515015019517155150

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump medication-dosage application softwareA software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709205281BivonaZT26IN40NGF212N2026-10-01
10887709205298BivonaZT26IN45NGF211N2026-10-01
10887709205304BivonaZT26IN45NGF210N2026-10-01
10887709205311BivonaSZ26IN60NGZ222N2026-10-01
10887709205328BivonaFT26IN35NGE217N2026-10-01
10887709205335BivonaHT26IS70NSC219N2026-10-01
10887709205342BivonaHT26IS80NSC218N2026-10-01
10887709205359BivonaSU26IN60NSC220N2026-10-01
10887709205366BivonaFT26IN40NGE221N2026-10-01
10887709205373BivonaFT26IN30NGF223N2026-10-01
10887709205380BivonaFU26JN50NGF001N2026-10-01
10887709205397BivonaHT26JS85NSC002N2026-10-01
10887709205410BivonaXA26JS60NGF004N2026-10-01
10887709205427BivonaFU26JN40NGE003N2026-10-01
10887709205014BivonaFT26IN70NSZ174N2026-09-30
10887709205021BivonaZU26IS45NGF176N2026-09-30
10887709205038BivonaZU26IS40NGF175N2026-09-30
10887709205045BivonaZT26IN35NSB180N2026-09-30
10887709205052BivonaFU26IN40NGZ015N2026-09-30
10887709205069BivonaZT26IN50NGC149N2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046955582969Perfusor®B. BRAUN MEDICAL INC.MRZ2026-06-07
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
10610586043307MedfusionICU MEDICAL, INC.MRZ2022-03-29
B553BYRAMCONNECT100ByramConnectWELLDOC, INC.MRZ2021-09-27
B553BYRAMCONNECTRX100ByramConnect RxWELLDOC, INC.MRZ2021-09-27
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517154290CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154887CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154894CADDICU MEDICAL, INC.MRZ2019-12-05
15019517151107PharmGuardICU MEDICAL, INC.MRZ2019-12-02
15019517154306MEDFUSIONICU MEDICAL, INC.MRZ2019-09-18
15019517154313MEDFUSIONICU MEDICAL, INC.MRZ2019-09-18
15019517154320MEDFUSIONICU MEDICAL, INC.MRZ2019-09-18
15019517130928MedfusionICU MEDICAL, INC.MRZ2019-03-08
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
10887787007265SapphireICU Medical, Inc.MRZ2018-06-04
10887787007272SapphireICU Medical, Inc.MRZ2018-06-04
10887787007302SapphireICU Medical, Inc.MRZ2018-06-04
10887787007319SapphireICU Medical, Inc.MRZ2018-06-04
10887787007357SapphireICU Medical, Inc.MRZ2018-06-04
10887787007364SapphireICU Medical, Inc.MRZ2018-06-04
10887787007395SapphireICU Medical, Inc.MRZ2018-06-04
10887787007401SapphireICU Medical, Inc.MRZ2018-06-04