Medfusion

Primary DI
10610586042867
Brand
Medfusion
Company
ICU MEDICAL, INC.
Model
67-2449-0300-51
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
10610586042867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058604286710610586042867

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
10887709199870BivonaFU26GN40NSC236N2026-07-30
10887709199887BivonaFU26GN30NSC235N2026-07-30
10887709199894BivonaFU26GN30NSF235N2026-07-30
10887709199689BivonaFU26GN60NGF229N2026-07-29
10887709199696BivonaFT26GN45NSF228N2026-07-29
10887709199702BivonaST26GN50NGF231N2026-07-29
10887709199719BivonaFT26GN40NGF230N2026-07-29
10887709199726BivonaFT26GN65NSC225N2026-07-29
10887709199733BivonaSU26GN45NSC223N2026-07-29
10887709199740BivonaSU26GN40NSC222N2026-07-29
10887709199757BivonaFT26GN60NSF232N2026-07-29
10887709199658BivonaFT26GN25NSA221N2026-07-28
10887709199665BivonaST26GN55NSB224N2026-07-28
10887709198804BivonaFT26GN45NSF145N2026-07-27
10887709199252BivonaFU26GN50NSF160N2026-07-27
10887709199269BivonaFT26GN55NGF161N2026-07-27
10887709199276BivonaFP26GN40NSF163N2026-07-27
10887709199283BivonaFU26GN45NSA164N2026-07-27
10887709199290BivonaFT26GN40NGE162N2026-07-27
10887709199306BivonaFT26FN80NSC026S2026-07-27

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
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
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