Medfusion

Primary DI
10610586041549
Brand
Medfusion
Company
ICU MEDICAL, INC.
Model
67-2466-0200-51
Published
2016-11-16
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
10610586041549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058604154910610586041549

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
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
15019517154986CADDICU MEDICAL, INC.MRZ2020-02-28
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517154290CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154887CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154894CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154993CADDICU 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